Doi 10 1016 2FB978 0 08 055294 1 00270 1 Efron N Comprehensive Biomaterials Development of Contact Lenses From A Biomaterial Point of View PDF

6.633.
Development of Contact Lenses from a Biomaterial Point of

View – Materials, Manufacture, and Clinical Application
N Efron, Queensland University of Technology, Kelvin Grove, QLD, Australia
C Maldonado-Codina, The University of Manchester, Manchester, UK
ã 2011 Elsevier Ltd. All rights reserved.
6.633.1. Introduction 519

6.633.2. General Properties of Hydrogel Materials of Relevance to Contact Lenses 520
6.633.2.1. Optical Transparency 520
6.633.2.2. Mechanical Properties 520
6.633.2.3. Surface Properties 521
6.633.2.4. Water Content 522
6.633.2.5. Oxygen Permeability 522
6.633.2.6. Fluid and Ion Permeability 522
6.633.2.7. Refractive Index 523
6.633.2.8. Swell Factor and Dimensional Stability 523
6.633.3. Conventional Hydrogel Contact Lens Materials 523
6.633.3.1. Historical Development 523
6.633.3.2. Polymeric Formulations 523
6.633.3.3. High Water Content Hydrogel Lenses 525
6.633.3.4. Strategies for Enhancing Lens Comfort 525
6.633.4. Silicone Hydrogel Contact Lens Materials 527
6.633.4.1. The Drive for Increased Corneal Oxygenation 527
6.633.4.2. The Challenge of Incorporating Silicone into Hydrogel Materials 527
6.633.4.3. The Launch of Silicone Hydrogel Lenses 528
6.633.4.4. Surface Treatments 528
6.633.4.5. Material Modulus of Elasticity 528
6.633.4.6. Lens Edge Design 528
6.633.4.7. ‘Second Generation’ Silicone Hydrogel Lenses 528
6.633.4.8. Optimizing Surface Characteristics 528
6.633.5. Classification of Soft Contact Lens Materials 530
6.633.6. Soft Contact Lens Manufacture 530
6.633.6.1. Lathe Cutting 530
6.633.6.2. Spin Casting 531
6.633.6.3. Cast Molding 532
6.633.6.4. Reproducibility and Quality of Mass-Produced Lenses 532
6.633.7. Clinical Ramifications of Polymer and Manufacturing Developments 534
6.633.7.1. Polymer Developments: Enhanced Corneal Oxygenation 536
6.633.7.2. Manufacturing Developments: Planned Lens Replacement 538
6.633.8. Conclusions 539
Appendix A. Classification of Soft Lens Materials 539
A.1. FDA Classification System 539
A.2. ACLM Classification System 539
A.3. BS EN ISO 18369-1: 2006 540
A.3.1. Example 540
References 540
Glossary Conjunctival staining Disruption of the superficial

Conjunctiva Clear transparent vascularized protective tissue epithelial layer of the conjunctiva, as revealed by an
layer that covers the white sclera of the eye. The conjunctiva orange dye (fluorescein) that is inserted into the eye.
also lines the inside of the eyelids. Fluorescein fills spaces created by tissue damage, and
Conjunctival flap formation Deep folds in the conjunctiva the pooled dye displays a bright green fluorescence when
caused by pressure from the edge of a soft contact lens, illuminated with blue light, revealing the location of
resulting in a flap of tissue. tissue damage.
517
518 Other Surgical Disciplines: Ophthalmology
Contact lens A clear, transparent shell-like optical appliance impeding the passage of light into the eye, resulting in
that is placed on the front of the eye to correct errors of partial or complete vision loss.
refraction of the eye. Mucin balls Small spherical balls of mucin, derived from
Cornea The clear transparent tissue at the front of the eye mucin in the tear layer, that form between the back of the
through which light passes to form an image at the back of lens and front of the cornea, during lens wear.
the eye. Myopia Nearsightedness, whereby the image of a distant
Corneal staining Disruption of the superficial epithelial object in space is focused in front of the light-sensing retina
layer of the cornea, as revealed by an orange dye at the back of the eye. This is corrected using minus powered
(fluorescein) that is inserted into the eye. Fluorescein fills ophthalmic lenses.
spaces created by tissue damage, and the pooled dye displays Papillary conjunctivitis An inflammation of the vascular
a bright green fluorescence when illuminated with blue mucous tissue on the inside of the eyelid, caused by
light, revealing the location of tissue damage. irritation of the front surface of the contact lens, especially of
Endothelial cell density The number of endothelial cells the lens surface if contaminated with deposits.
per unit area of the endothelial surface. Prelens tear film The thin layer of tears that covers the
Endothelial polymegethism Change in appearance of the cornea and conjunctiva of the eye.
endothelium, whereby the cells in this layer display a large Presbyopia The reducing ability of the eye to focus on close
variation in cell size. objects, caused by a thickening and loss of flexibility of the
Endothelium Single layer of highly metabolically active lens inside the eye.
cells at the back of the cornea. The cells all appear to be of Stroma Forms the bulk of the middle of the cornea,
uniform size and display, and characteristic hexagonal consisting of collagen fibrils and mucopolysaccharide
shape. ground substance.
Epithelium Superficial layer of cellular tissue of an organ, Superficial epithelial arcuate lesions (SEALs) Arc-shaped
such as the cornea. lesion of the superficial tissue of the cornea, occurring at the
Epithelial microcysts Small cystic spheres that form within surface of the cornea. This is a transient form of tissue
the corneal epithelium, when subjected to hypoxic stress. damage that is self-limiting; that is, it heals by itself within
Epithelial oxygen uptake The movement of oxygen into the 24 h if the lenses are removed.
cornea, from either the atmosphere in front of the eye, or the Trial fitting The process of sequentially applying contact
aqueous humor (the fluid inside the eye). lenses with different characteristics (curvature, diameter,
Fluorescein staining A term describing the use of thickness, material, etc.) to the eye and assessing lens behavior
fluorescein to reveal the presence of tissue damage in the on the eye (stabilized position, movement with blink, etc.)
cornea or conjunctiva (see ‘corneal staining’ and until a lens fitting of satisfactory performance is achieved.
‘conjunctival staining’). Xerogel The anhydrous polymer from which soft lenses
Microbial keratitis Inflammation of the cornea caused by may be made; water needs to be added to turn the xerogel
infection with microorganisms. This inflammatory process into a functional hydrogel.
can result in opaque scar formation on the cornea, thus
Abbreviations FM0411M Methacryloyloxyethyl

ACLM Association of Contact Lens Manufacturers iminocarboxyethyloxypropyl poly
(United Kingdom) (dimethylsiloxy)-butyldimethylsilane
AFM Atomic force microscopy GlyMA Glyceryl methacrylate
AMA Alkyl methacrylate GMA Glyceryl methacrylate
BMA Butyl (probably isobutyl) methacrylate HEMA Hydroxyethyl methacrylate
BS British Standards HOB 2-hydroxybutyl methacrylate
CMA Cyclohexyl methacrylate IBM Isobornylmethacrylate
Dk Oxygen permeability (diffusivity [D] ISO International Standardization Organization
solubility [k]) M3U Bis(methacryloyloxyethyl iminocarboxy
Dk/t Oxygen transmissibility (Dk divided by ethyloxypropyl) poly(dimethylsiloxane)-poly
thickness [t]) (trifluoropropylmethylsiloxane) poly
DAA Diacetone acrylamide (methoxy-poly[ethyleneglycol]
DMA N,N-dimethyl acrylamide propylmethylsiloxane)
EEMA Ethoxyethyl methacrylate MAA Methacrylic acid
EGDMA Ethylene glycol dimethacrylate MMA Methyl methacrylate
EN European Norm MPDMS Monofunctional polydimethylsiloxane
EWC Equilibrium water content NCVE N-carboxyvinyl ester
FDA Food and Drug Administration NPDC National Patent Development Corporation
Development of Contact Lenses from a Biomaterial Point of View – Materials, Manufacture, and Clinical Application 519
NVP N-vinyl pyrrolidone SFrad Radial swell factor

PBVC Poly(dimethysiloxy) di (silylbutanol) bis SIA Siloxanyl acrylate
(vinyl carbamate) SIMA Siloxanyl methacrylate
PC Phosphoryl choline TAIC 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-
PDMS Polydimethyl siloxane trione
pHEMA Poly(hydroxyethyl methacrylate) TEGDMA Tetraethyleneglycol dimethacrylate
PLTF Prelens tear film TPVC Tris-(trimethyl siloxysilyl) propylvinyl
PMMA Polymethyl methacrylate carbamate
PVP Polyvinyl pyrrolidone TRIS Tris(trimethylsiloxy)-methacryloxy-
SEALs Superior epithelial arcuate lesions propylsilane
SEM Scanning electron microscopy USAN United States assigned name
SF Swell factor VA Vinyl acetate
SFax Axial swell factor VMA N-vinyl-N-methylacetamide
6.633.1. Introduction accepted as being their lack of comfort and, in particular,

their initial discomfort.3 Figure 1 illustrates the demise in
Soft contact lenses have had a massive impact on the global rigid lens fitting over the past 40 years in Australia – a country
contact lens market since their introduction into the market in in which fitting trends have been well documented over this
the early 1970s. Over the past 50 years, the number of soft period.
contact lenses being prescribed around the world has steadily Second, advances in manufacturing technology have directed
increased, and it is mainly the sale of soft contact lenses which the industry toward soft lenses and, still further, toward the
is responsible for an industry which is estimated to be worth concept of disposability. In view of the above, rigid contact
around US$8 billion annually (this figure does not include the lenses will not be discussed in this chapter.
sale of contact lens solutions). A recent survey has indicated Contact lens materials are good examples of biomaterials;
that soft lenses currently make up over 92% of all new contact indeed, they are classed as a medical device in most countries.
lens fittings worldwide.1 Biomaterials manufactured for use as contact lenses must not
The saturation of the contact lens market with soft only satisfy the requirements of not having toxic or injurious
lenses has occurred primarily for two reasons. First, soft lenses effects for safe use within the eye, but additionally they must
provide wearers with what they see as the two most impor- also have very specific characteristics, such as being transparent
tant requirements for successful contact lens wear – good (and remain so on-eye), comfortable, and relatively cheap to
vision and good comfort. Rigid lenses, which were originally manufacture.
made from glass (between 1888 and 1940) and later from This chapter will review the properties and characteristics
polymethyl methacrylate (PMMA) or silicone acrylate materi- of the materials which are used to manufacture soft contact
als, are uncomfortable to wear. They are now seldom fitted lenses, provide some of the history of development of these
to new patients and are rapidly becoming obsolete.2 The major materials, introduce the nomenclature used to categorize con-
obstacle as far as rigid lenses are concerned is generally tact lens materials, describe current approaches to contact lens
100
Bionite soft lenses
first fitted in
Australia
80
Rigid lens fits (%)
Holden (1975)
60 Holden (1977)
Holden (1980)
Swarbrick (1984)
40
Holden (1988) Efron, Morgan and Woods
(2000–2010)
Sweeney (1989)
20
0
1970 1975 1980 1985 1990 1995 2000 2005 2010
Year
Figure 1 Decline in rigid contact lens new fits, as a proportion of all contact lenses fitted, between 1970 and 2010.
manufacture, and highlight the clinical implications of these they are hydrophilic, hydrogels take up water, which causes
developments. them to become soft with elastic properties (the water acts as a
plasticizer).
Unlike perfectly elastic materials which deform under stress
6.633.2. General Properties of Hydrogel Materials of
but return to their original size and shape when the stress is
Relevance to Contact Lenses
released, hydrogels are viscoelastic. This means that they
deform time dependently when a stress is applied to them
The ocular environment places significant demands on the
and recover time dependently when the stress is removed.
performance of hydrogels as biomaterials. These materials
Theoretically, this can result in permanent deformation of the
must have the following properties:
material.
• maintain a stable, continuous tear film; One of the main difficulties in characterizing the mechanical
• be permeable to oxygen in order to maintain normal properties of a contact lens is that there is no single property
corneal metabolism; measurement which will accurately reflect its ‘in use’ situation.
• be permeable to ions in order to maintain on-eye Contact lens hydrogels typically do not demonstrate a yield
movement; point. The strength of a hydrogel gives some indication of the
• be comfortable; behavior of the material during handling, while the modulus
• provide clear, stable vision. indicates the extent to which the eyelid will deform it and has an
impact on the fitting characteristics of the lens. Rigid lens mate-
These essential properties are expanded upon below.
rials have a relatively high modulus (in the region of 103 MPa)
whereas soft lens materials have a much lower value when in the
6.633.2.1. Optical Transparency
hydrated state. The advantage of a lower value associated with
A hydrogel to be used as a contact lens material needs to be greater comfort can be offset by poor visual performance.
transparent in order to achieve maximal visual performance. New generation silicone hydrogel lenses have a higher
The light transmittance properties of polymers can be categor- tensile modulus (1.1–1.4 MPa) compared with conventional
ized as being transparent, translucent, or opaque. Transparent hydrogels (0.2–0.6 MPa). The higher moduli of silicone hydro-
polymers are those that you can see through, translucent poly- gel materials have certain clinical implications which are dis-
mers are those that you cannot see through but allow light to cussed in more detail in Section 6.633.4.
pass through, and opaque polymers are those that neither The generally poor mechanical strength (including tear
permit you to see through nor allow light to pass through. strength) of soft lenses is arguably the main reason why they
Usually, the optical clarity of contact lens materials is expressed have relatively short lifetimes. This problem has been some-
as the percentage of transmission of the visible electromagnetic what overcome by the introduction of disposable lenses, which
spectrum. Hydrogels which are useful as contact lens materials essentially means that the majority of soft lenses no longer
transmit over 90% of light in the visible part of the spectrum. need to last more than a day, 2 weeks, or a month depending
When a hydrogel loses its transparency, it is likely to be due on their intended replacement schedule.
to microphase separation of water. This is due to regions of Several factors can affect the mechanical properties of
differing refractive index being formed within the gel. Hydro- a hydrogel material and these can be broadly divided into
gels that show this type of behavior – typically synthesized (a) material composition factors and (b) polymer processing
by making copolymers with large blocks or segments of hydro- factors. Examples of material composition factors include
phobic and hydrophilic monomers rather than randomly dis- changing the comonomers used in the hydrogel preparation.
persing them – do have advantages in terms of enhanced If the hydrogel is not a homopolymer, then increasing the
strength and permeability performance. relative amount(s) of physically stronger component(s) will
If the phase separation is limited (e.g., the phase size is lead to an increase in the final mechanical strength of the
shorter than the wavelength of light), transparent materials can material. This may have the effect of altering the mechanical
still be obtained. Some hydrogels are known to lose their trans- strength by increasing the stiffness of the backbone polymer by,
parency when heated, and this is an important consideration as for example, replacing acrylates with methacrylates, or it may
there is an increase in temperature from lens packaging to eye. alter the hydrophilicity of the polymer by, for example, repla-
Additionally, some lens wearers still thermally disinfect their cing hydroxyethyl methacrylate (HEMA) with methacrylic acid
lenses although this approach is seldom used at the present time. (MAA). In general, as the equilibrium water content (EWC) of a
hydrogel increases, its modulus decreases.
The mechanical properties of a hydrogel are dependent on
6.633.2.2. Mechanical Properties
the cross-link density in the system. In general, the strength of
The mechanical properties of hydrogel contact lenses are a hydrogel increases with increasing cross-link density, partic-
fundamentally important because they are directly related ularly when in the swollen state where physical entanglements
to factors such as comfort, visual performance, fitting charac- are low. Cross-link density can be increased by the addition of
teristics, physiologic impact, durability, and handleability of larger amounts of cross-linking agent. Although increasing the
the lenses. cross-link density within a hydrogel network is beneficial in
In the hydrated state, most hydrogels are soft and flexible. relation to its mechanical properties, it must also be considered
When they are allowed to dehydrate, they become hard and that changes to other properties of the polymer will occur.
brittle. Lower water content polymers tend to become more The swelling capacity of the hydrogel is likely to be reduced
hard and brittle than higher water content materials. Because with increasing cross-link density, and hence, its oxygen
permeability will also be reduced which is undesirable in a the contact angle of the drop with the surface to which it is
contact lens material. A balance of all the properties of a applied (Figure 2). Figure 3 shows the contact angles of a
polymer is critical to its end application. conventional hydrogel and a silicone hydrogel. Note that the
Polymer processing factors which can affect the mechanical contact angle of the silicone hydrogel is considerably larger than
properties of a hydrogel essentially refer to the fact that hydrogel that of the conventional contact lens. However, it is important
materials are highly sensitive to the processing and fabrication to bear in mind that the wettability of a given surface depends
conditions to which they are subjected. Lenses made by different on a number of factors including the surface tension of the test
methods of manufacture will undergo very different material liquid and as such, it is a property of a liquid–solid combination
processing – particularly polymerization. These different mate- rather than of the solid surface alone.
rial processing steps may have an effect on the mechanical The contact angles obtained for a lens–liquid combination
properties of the resultant lens. For example, lathed lenses are are highly methodologically dependent4,5 and any reporting of
formed from solid buttons of dehydrated material. The buttons contact angles should include experimental details such as the
are usually bulk polymerized over relatively long periods. method itself, the probe liquid, and prior treatment of the
Thermal initiators that have low activation energies are often material under test.
used, thereby allowing water baths or ovens to be set to relatively The sessile drop and the captive bubble techniques give
low temperatures. This type of polymerization is likely to lead discrepant results for a single sample because a different type
to a polymer structure consisting of longer chains (higher molec- of contact angle is measured in each technique: an advancing-
ular weights) and, therefore, more chain entanglements. type contact angle is measured in the sessile drop technique
In the cast-molding process, a small amount of monomer and a receding-type contact angle is measured in the captive
is placed between two casts to directly form the lens. The bubble technique.
polymerization process is typically very fast which is one of The receding contact angle obtained in vitro is especially
the reasons why this is the method of choice for bulk (dispos- relevant when considering the performance of a contact lens
able) lens manufacture (see Section 6.633.6.3). Rapid poly- in vivo. The advancing angle corresponds more to the establish-
merization times are likely to produce shorter chains, more ment of the tear film which is assisted mechanically by the
chain ends, and less efficient cross-links. eyelid. Conversely, the receding angle is thought to be impor-
tant in the stability of the tear film between blinks.
6.633.2.3. Surface Properties
The surface characteristics of a hydrogel lens will directly affect
its interactions with the tear film and consequently its biocom-
patibility in the ocular environment. ‘Wettability’ is used to
describe the tendency for a liquid to spread on to a solid Vapor
surface, and in vivo wettability in a contact lens context implies
the ability of the tear film to spread and maintain itself over a Liquid
contact lens surface. In vivo wettability is a key measure of q
clinical performance because the success of any contact lens
is considered to be related to its ability to support a stable tear Solid
layer in the eye. General clinical consensus is that failure to
meet this requirement is likely to result in a lens which is
uncomfortable, has reduced visual performance, and deposits Figure 2 Schematic representation of the sessile drop technique
showing the contact angle (y) measured when a drop is placed on a solid
rapidly. The quality of the prelens tear film (PLTF) will also have
surface. Adapted from Maldonado-Codina, M.; Efron, N. In Contact Lens
an effect on the friction between the eyelid and the lens surface.
Practice, 2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/Elsevier:
This in turn is thought to be important in the etiology of phys- Maryland Heights, MO, 2010; p 72.
iologic responses such as contact lens-related papillary conjuncti-
vitis. The issue of wettability has received considerable attention
since the introduction of silicone hydrogel materials at the turn
of the century, in view of the potentially poor wettability of
untreated lenses manufactured from this material.
In vivo wettability is generally assessed using a range of
relatively crude clinical tests which have been used for several
decades. These include tear film break-up time (with or with-
out the presence of fluorescein stain), interferometric techni-
ques, and various techniques based around specular reflection.
Unfortunately, these methods frequently fail to adequately
differentiate between lens surface types, even when relatively
Figure 3 Sessile drop contact angle images of a conventional hydrogel
different lens surfaces are evaluated. lens (left) and a silicone hydrogel lens (right). Note the larger contact
On the other hand, laboratory measures of wettability are angle for the silicone hydrogel material. Reprinted with permission from
well established and are better at differentiating lens surfaces. Maldonado-Codina, M.; Efron, N. In Contact Lens Practice, 2nd ed.;
Wettability in relation to contact lenses has traditionally been Efron, N., Ed.; Butterworth-Heinemann/Elsevier: Maryland Heights, MO,
assessed in vitro using the sessile drop technique and measuring 2010; p 73.
6.633.2.4. Water Content refractive index methods as valid techniques for measuring
the EWC of a hydrogel lens.8,9 The thermogravimetric method
The EWC of a hydrogel lens is defined as follows:
involves measuring the weight of a lens in the hydrated state
Weight of water in polymer and then remeasuring the lens in the completely dehydrated
EWC ¼ 100 state. The disadvantages of this method are that it is time
Total weight of hydrated polymer
consuming and essentially destroys the lens.
The EWC of a hydrogel may vary depending on the environ-
mental conditions. For example, pH, tonicity, and temperature
may alter the EWC of a hydrogel. Increased temperature is an 6.633.2.5. Oxygen Permeability
important consideration because there is a significant increase in
temperature when a contact lens is taken from its packaging As the cornea receives most of its oxygen from the atmosphere,
solution (normally at room temperature) and placed on the eye. the oxygen transmissibility profile of a contact lens is one of its
Most contact lens hydrogels will undergo a small change in EWC most important properties. Oxygen permeability is a property
when placed in solutions of different pH and osmolality, but of the material itself and is described as the Dk, where D is the
these changes will be most pronounced in ionic lens materials. diffusivity of the material and k is the solubility of the material.
The surface EWC of a contact lens can be measured using Oxygen permeability of a hydrogel will vary with temperature.
a soft contact lens refractometer.6 This is a simple hand-held Oxygen permeability is essentially governed by EWC in
optical instrument which can be readily used in the clinical conventional hydrogels. This relationship is on the basis of
setting. More sophisticated electronic versions of this instrument the ability of oxygen to pass through the water rather than
are also available.7 The principle underlying the capacity of a through the material itself. The relationship between EWC
refractometer to determine contact lens water content is the and oxygen permeability has been found to be10:
inverse relationship between refractive index and EWC of hydro-
Dk ¼ 1:67e0:0397EWC
gel materials. The measured refractive index of a contact lens is
converted to percent water which is read directly from the inter- where e is the natural logarithm (Figure 4).
nal scale. This approach does assume that dehydrated hydrogels In order to calculate the amount of oxygen which will move
have the same refractive index, which is not strictly true. How- from the anterior to the posterior surface of a lens, the oxygen
ever, errors due to small differences between hydrogel polymers permeability (Dk) is divided by the thickness of the lens (t).
in respect of refractive indices are clinically inconsequential. The units of Dk and Dk/t are as follows8,9:
Difficulties are also encountered with this instrument when
attempting to measure the EWC of silicone hydrogel lenses. ðDkÞ in Dk units ¼ 1011 cm2 ml O2 =ðs ml hPaÞ
These lenses have a lower refractive index compared to conven- ðDk=t Þ in Dk=t units ¼ 109 ðcm ml O2 Þ=ðs ml hPaÞ
tional hydrogels and their EWC is overestimated with the soft
contact lens refractometer. Additionally, as it is surface EWC
which is being measured with this instrument, it is unknown
6.633.2.6. Fluid and Ion Permeability
what effect the surface coatings on some of these lenses have
on the final result. The development of silicone hydrogel materials has high-
British and ISO (the International Organization for Stan- lighted the importance of the so-called ‘hydraulic permeability’
dardization) Standards specify both thermogravimetric and or water transport of a contact lens material. Essentially, a
180
Silicone hydrogel
160
Conventional hydrogel
Night and day
Oxygen permeability (barrers)
140
PremiO Biofinity
120
Air Optix TruEye
100 Oasys Avaira
80 PureVision
60
Advance Clariti
40
20
0
0 10 20 30 40 50 60 70 80
Water content (%)
Figure 4 Relationship between oxygen permeability and equilibrium water content for conventional hydrogel lenses (solid curve) and silicone
hydrogels (dashed curve).
minimum level of hydraulic (as well as ionic) permeability is SFrad ¼ ðSFdia Þ2 =SFax
necessary to maintain adequate lens movement. This is impor-
tant in allowing the postlens tear film to reform between where SFrad is the radial swell factor, SFdia is the diametral swell
blinks, thus reducing the likelihood of these quite elastic lenses factor, and SFax is the axial swell factor.
from binding to the cornea. Water is able to move through
a hydrogel in a way quite different from the movement of 6.633.3. Conventional Hydrogel Contact Lens
sodium ions, that is, it is more difficult for sodium ions to Materials
travel through the gel, as in order to do so they must be
accompanied by a shell of water.11 In the eye, the sodium ion Hydrogel materials can be conveniently divided into two
permeability of contact lens materials is particularly important groups: (1) conventional hydrogel materials (now sometimes
as it is a major constituent of the tear film. Sodium ion trans- referred to as low Dk materials) and (2) silicone hydrogels
port is impeded in gels with a water content below 20%. (high Dk materials). This section will discuss conventional
hydrogel materials.
6.633.2.7. Refractive Index
6.633.3.1. Historical Development
Ideally, a hydrogel fabricated for contact lens materials should
have a refractive index similar to that of the cornea, that is, near Hydrogel lenses were developed as a result of the extraordinary
to 1.37. The variation of refractive index with EWC in conven- pioneering efforts of Professor Otto Wichterle (Figure 5) and
tional hydrogels is almost linear, with most hydrogel refractive colleagues in the Institute of Macromolecular Chemistry
indices falling within 1.46–1.48 at 20% water content and of the Czechoslovak Academy of Sciences in Prague in the
1.37–1.38 at 75% water content, that is, the refractive index mid-1950s. Essentially, Wichterle was working on the synthesis
decreases with increasing water content. Because of this rela- of a new material that he hoped could be used for implantation
tionship, it is possible to calculate the refractive index of a into the human body. That material was poly(hydroxyethyl
hydrogel if its EWC is known (and vice versa), which is the methacrylate) or pHEMA.14 Wichterle soon realized that the
basis for the use of the soft contact lens refractometer, as material had potential applications in the manufacture of con-
discussed in Section 6.633.2.4. tact lenses, but he was prevented from researching such a
It is unlikely that a relationship between refractive index project by the directors of the Institute, who perceived this
and water content will hold for all silicone hydrogel lenses on work as being a petty distraction from fundamental studies in
the market as many are fabricated on the basis of completely chemistry. He was forced to carry out his experiments at home.
different material chemistries. British and ISO Standards rec- Despite such difficult circumstances, he successfully managed
ommend the use of an Abbe refractometer to measure the to produce the first spun-cast lens (made from his son’s toy
refractive index of a hydrogel contact lens.8,9 However, other construction set) in 1961.15 The enormity of his breakthrough
more automated instruments have been used for the assess- for the contact lens industry cannot be overstated.
ment of hydrogel lens refractive index.7,12,13
6.633.3.2. Polymeric Formulations
6.633.2.8. Swell Factor and Dimensional Stability HEMA (Figure 6) is made by polymerizing 2-hydroxyethyl
The dimensional stability of a hydrogel lens refers to its ability methacrylate monomer with a cross-linker such as ethylene
to maintain its original dimensions under various conditions. glycol dimethacrylate (EGDMA) (Figure 6). Most of the hydro-
It is dependent on any factor that will change the water philic behavior of HEMA is due to the presence of the hydroxyl
content of the hydrogel or the swelling behavior of the hydro-
gel. Factors that influence the swell factor of a hydrogel
include temperature, pH, and tonicity. The swelling behavior
of a hydrogel is particularly important during the manufac-
ture of contact lenses in the dry state, for example, when a soft
contact lens is lathed. During the lathing process, a smaller,
steeper lens of greater power is made so that when it is
hydrated, it swells to the required dimensions and power
required. It is vital, therefore, that the swell factors of the
material are accurately known. The swell factor is described
by the following relationship:
Swell factor ðSFÞ ¼ Wet dimension=dry dimension

Initially, it was thought that a hydrogel material swelled
isotropically. Over time, it was found that the consistently
anomalous swelling behavior of hydrogels could only be
explained by specifying two swell factors. These swell factors
are those in the diameter and axial (thickness) directions. From
these, the value of the radial swell factor of a contact lens can
be calculated using the following equation: Figure 5 Otto Wichterle.
CH3 higher water contents. Producing lenses which were thinner

was a relatively straight forward matter for lens designers and
CH2 C
CH3
several such lenses were launched, for example, the Hydro-
C O H curve thin lens (Soft Lenses, Inc.) in 1977 and subsequently
CH2 C CH3
O CH2 C the O3 Series (Bausch & Lomb). These lenses were in the region
C O CH2 C of 0.035–0.06 mm in thickness which was less than half the
CH2 N O
thickness of the original Bausch & Lomb pHEMA lenses.
CH2 C C O
O Developing materials with higher EWC led to the successful
CH2
CH2 CH2 CH3 OH development of HEMA copolymers. One of the first success-
OH ful copolymerizations was with N-vinyl pyrrolidone (NVP)
HEMA NVP MMA MAA (Figure 6). The amide (N–C¼O) moiety is very polar and two
molecules of water can become hydrogen bonded to it. NVP-
CH3 based copolymers lose the slippery ‘feel’ of pHEMA and conse-
CH2 C quently can feel quite rubbery. These copolymers also tend to
CH3 have relatively high evaporation rates of water which may be seen
C O
as a problem for lens stability and comfort. This occurs because
CH2 C
O H the amide group does not bind water as strongly as a hydroxyl
C O group. In addition, these polymers are significantly more
CH2 CH2 C
temperature-sensitive than pHEMA-based materials; that is,
O
CH2 C O their parameters tend to change with increasing or decreasing
CH2 temperature. This is important when removing a lens from its
O N
CHOH
packaging (at room temperature of, say, 20 C) and inserting it
CH3 CH3
C O into the eye (33 C); that is, lens parameters may change on-eye.
CH2OH NVP-based lenses have also been associated with increased
CH2 C
toxic reactions to the corneal epithelium – observed as patches
CH3 of ‘staining’ on the corneal surface, which are observed clini-
EGDMA GMA DMA cally with the aid of fluorescein dye16 – and decreased comfort
when used in conjunction with solutions containing higher
Figure 6 Some of the monomers used in conventional hydrogel lens
materials. HEMA, hydroxyethyl methacrylate; NVP, N-vinyl pyrrolidone; levels of polyhexanide.17,18 This does not mean that
MMA, methyl methacrylate; MAA, methacrylic acid; EGDMA, ethylene polyhexanide-based solutions cannot be used with NVP-
glycol dimethacrylate; GMA, glyceryl methacrylate; DMA, N,N-dimethyl containing lenses, rather the interaction should be born in
acrylamide. Adapted from Maldonado-Codina, M.; Efron, N. In Contact mind if any significant corneal staining or discomfort symp-
Lens Practice, 2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/Elsevier: toms arise – these can usually be treated simply by changing
Maryland Heights, MO, 2010; p 75. the solution to one containing a lower level of polyhexanide
or one free from polyhexanide.
group (OH) at the end of the monomer. At this location in the Methyl methacrylate (MMA) is the material from which rigid
resultant polymer, hydrogen bonding with water molecules contact lenses are originally made, that is, PMMA (Figure 6).
occurs, causing them to be drawn into the polymer matrix. When MMA and NVP are copolymerized, a completely new
The result is that contact lenses made from pHEMA contain material is obtained with very different characteristics to the
approximately 40% water in the fully hydrated state. HEMA/NVP (also known as HEMA/VP) copolymers. Depend-
Lenses fabricated from pHEMA were first distributed in West- ing on their composition, contact lenses made from MMA/VP
ern Europe in 1962 but sales were disappointing. In 1965, the copolymers can contain 60–85% water. MMA is very hydropho-
National Patent Development Corporation (NPDC) bought bic but is useful in soft lens hydrogels as it gives the resultant
the licence for the American rights to the technology from the polymers increased mechanical strength.
Czechs. This was subsequently sold on to Bausch & Lomb who at Another hydrophilic monomer that has been very success-
that time manufactured ophthalmic equipment and spectacle fully used in contact lens hydrogels is MAA (Figure 6). When
lenses. Bausch & Lomb significantly refined Wichterle’s spin- added to a soft lens polymer formulation, it results in a soft
casting process and finally obtained approval from the Food lens with ionized groups (negatively charged) within the poly-
and Drug Administration (FDA) for their pHEMA lenses in mer matrix, allowing the lens to absorb more water. The higher
1971. This time, the lenses quickly became very popular – both the amount of MAA, the higher the EWC of the resulting
practitioners and patients enjoyed the benefits of increased com- polymer. Amounts of MAA in the region of 1.5–2.5% will
fort, reduced adaptation time, and easier fitting procedures. With increase the water content of a HEMA material into the mid-
time, more and more companies developed their own pHEMA water content range of 50–60%, thereby allowing oxygen per-
lenses; however, it soon became clear that these lenses were not meability to increase significantly.
problem-free. Most of these problems stemmed from the fact Once HEMA/MAA lenses have been manufactured, they
that the lenses caused hypoxia but other problems relating to need to be ionized (i.e., the hydrogen atom in the carboxyl
solution toxicity and lens spoliation were also common. group is removed). The conversion of the carboxyl group
Contact lens manufacturers, therefore, had two possible (CO2H) to the more hydrophilic ionized form (the carboxylate
avenues to follow to increase the oxygen transmissibility of anion, CO 2 ) produces an increase in water content. This is
lenses: develop ‘hyper-thin’ lenses or develop materials with commonly achieved by washing the lenses in sodium
bicarbonate solution or buffered saline and is referred to as overnight or continuous basis. He developed the first extended
‘expanding the matrix.’ Unfortunately, using MAA to increase wear lens to be distributed in the United Kingdom known
the water content of a polymer also has its disadvantages. These as Permalens.24 The lens material had an EWC of 71% and
include the following: was made from a HEMA/VP/MAA copolymer. In 1981, the lens
was given FDA approval for ‘extended wear’ of up to 30 days
1. A lens which is extremely sensitive to changes in tonicity.19 along with another lens, the Hydrocurve II (Wesley Jessen).
The Naþ ions present in saline solution have the effect of Slowly, other lenses were given approval for extended wear
‘shielding’ the carboxylate anions. In hypotonic solutions during the 1980s but along with the increase in demand for
(e.g., pure water), as these shielding ions are present to a far these lenses, so too came an increase in complications. In 1989,
lesser degree, more chain repulsion will occur, which studies were published which showed that the risk of microbial
increases the swelling of the network and consequently keratitis was 5–15 times greater for extended wear than daily
the EWC of the material. In hypertonic solutions, the wear.25,26 As a result, the FDA recommended that extended wear
reverse situation occurs and the material network shrinks, be limited to six consecutive nights and with that, the enthusi-
causing its EWC to decrease. asm for extended wear died down – that is, until the emergence
2. A pH-sensitive lens.20 If the pH of the solution in which the of silicone hydrogel lenses in the late 1990s.
lens is immersed is decreased (i.e., the hydrogen ion con- Table 1 lists some of the most common hydrogel lenses on
centration is increased), the carboxylate anions are more the market and groups them into their appropriate FDA classi-
shielded and the network becomes less expanded. This will fication. See Appendix A for details on the classification of
cause a decrease in the lens EWC. hydrogels.
3. A very significant level of protein buildup both on the lens
surface and within the lens matrix.21,22 However, it is the
6.633.3.4. Strategies for Enhancing Lens Comfort
biological activity of deposited proteins such as lysozyme
which is thought to be most relevant in biocompatibility In recent years, so-called ‘enhanced’ hydrogel daily disposable
issues such as contact lens-related papillary conjunctivi- lenses have been developed, such as 1 Day Acuvue Moist (John-
tis and comfort; that is, protein which remains active son & Johnson), Focus Dailes with AquaComfort (CIBA Vision),
(as opposed to becoming denatured) is thought to be bio- and SofLens daily disposable (Bausch & Lomb). These lenses
compatible. The protein deposited on HEMA/MAA lenses utilize techniques of macromolecular entrapment and/or release
has been found to denature to a significantly lower degree of hydrophilic surface-active polymers at the lens surface in order
compared to other lens materials.23 to improve end-of-day comfort by stabilizing the PLTF.
4. Dimensional instability when the lens is heat disinfected. The Focus Dailes with AquaComfort lens is manufactured
from nelfilcon A which essentially consists of a cross-linked
Glyceryl methacrylate (GMA) is more hydrophilic than
functionalized polyvinyl alcohol (PVA) macromer with the
HEMA because of the fact that the monomer contains two
addition of nonfunctionalized PVA.27
hydroxyl groups (Figure 6). This monomer has been used in
PVA and polyvinyl pyrrolidone (PVP) are common soluble
contact lens materials in two main ways. The first method has
polymeric components in comfort drops and artificial tears
used GMA in combination with MMA to produce materials
and have a viscous consistency at elevated concentrations and
which have water contents in the range of 30–42%. These mate-
molecular weights giving them good surface spreading charac-
rials are thought to be stiffer and stronger than pHEMA hydro-
teristics. The 1 Day Acuvue Moist lens is manufactured from
gels but their oxygen permeabilities are not ideal for in-eye use.
the etafilcon A polymer (HEMA/MAA) together with the incor-
The second method has been to use GMA in combination
poration of small concentrations of low-molecular-weight PVP
with HEMA to produce a high water, nonionic contact lens
into the ionic material network.
material (up to 70% has been possible). These contact lenses
The Focus Dailies ‘enhanced’ lenses contain more unfunc-
are said to be ‘biomimetic,’ that is, they are claimed to improve
tionalized PVA than the original lenses. Unfunctionalized PVA
biocompatibility by imitating the hydrophilic properties of
is a non-cross-linked PVA macromer of a carefully selected
mucin. Manufacturers also suggest that these lenses show a
molecular size which does not take part in the polymerization
low rate of dehydration and a rapid rate of rehydration, that
process and which is added to the monomer mix before
is, they have good ‘water balance ratios.’ In addition, the materi-
polymerization. No imbibing step after the lens is polymerized
als are thought to be relatively deposit resistant and seem to be
is required. This unfunctionalized PVA macromer is thus free
relatively insensitive to pH changes in the range of pH 6–10. An
to elute from the lens into the tear film throughout the day
example of such a lens is the hioxifilcon A material used in the
with each blink. This PVA is thought to emerge from the lens
Clear 1 Day lenses manufactured by Clearlab. Another example
matrix as ‘strands’ at the lens surface and it is this effect together
of a so-called ‘biomimetic’ lens is the Proclear lens (Cooper-
with the effect of soluble PVA in the tear film which is what
vision) which contains phosphoryl choline (PC) and HEMA. PC
is referred to as the ‘surface modification’ of these lenses.
is said to mimic the natural chemistry of cell membranes.
The released PVA may improve lens comfort by decreasing
the surface tension of the tears, or by mimicking mucin,
found naturally in the tear film.28
6.633.3.3. High Water Content Hydrogel Lenses
In the 1 Day Acuvue Moist lens, the PVP is ‘locked’ into the
In the early days of soft lens development, de Carle24 proposed lens matrix and is not released from the lens during wear. The
that if the EWC of hydrogel lenses could be sufficiently PVP is adsorbed on to the preformed lens surface after manu-
increased, then these lenses could be worn successfully on an facture from solution. The lens packaging states that the lenses
Table 1 Conventional soft (hydrogel) lenses
Name Manufacturer/supplier Principal components W (%) USAN nomenclature
FDA Group I (<50% EWC <0.2% ionic content)

Biomedics 38 Coopervision HEMA 38 Polymacon
CD Ultra Vision HEMA 38 Polymacon
Cibasoft CIBA Vision HEMA 38 Tefilcon-A
Classic CIBA Vision HEMA, VP, MMA 43 Tetrafilcon-A
CSI CIBA Vision GMA, MMA 38 Crofilcon-A
Durasoft CIBA Vision HEMA, EEMA, MAA 30 Phemfilcon-A
Frequency 38 CooperVision HEMA 38 Polymacon
Hydron Z4/Z6 Coopervision HEMA 38 Polymacon
Ultra Vision 38 Ultra Vision HEMA 38 Polymacon
Medalist 38 Bausch & Lomb HEMA 38 Polymacon
Menicon Soft Menicon HEMA, VA, PMA 30 Mafilcon-A
Omega 38 Ultra Vision HEMA 38 Polymacon
Optima 38 Bausch & Lomb HEMA 38 Polymacon
Sauflon 38 Sauflon HEMA 38 Polymacon
Seelite 38 Coopervision HEMA 38 Polymacon
SeeQuence Bausch & Lomb HEMA 38 Polymacon
Soflens 38 Bausch & Lomb HEMA 38 Polymacon
Softspin Bausch & Lomb HEMA 38 Polymacon
FDA Group II (>50% EWC <0.2 ionic content)
Actisoft 60 Coopervision GlyMA 60 Hioxifilcon-A
Excelens CIBA Vision PVA, MMA 64 Atlafilcon
ES 70 Coopervision AMA, VP 70 –
Focus Dailies CIBA Vision PVA 69 Nefilcon-A
Gentle Touch CIBA Vision MMA, DMA 65 Netrafilcon-A
Igel 67 Ultra Vision Optics MMA, VP, CMA 67 Xylofilcon-A
Omniflex Coopervision MMA, VP 70 Lidofilcon-A
Medalist 66 Bausch & Lomb HEMA, VP 66 Alphafilcon-A
Permaflex CIBA Vision MMA, VP 74 Surfilcon-A
Precision UV CIBA Vision MMA, VP 74 Vasurfilcon-A
Proclear Coopervision HEMA, PC-HEMA 62 Omafilcon-A
Rythmic Coopervision MMA, VP 73 Lidofilcon
Sauflon-55 Sauflon HEMA, VP 55 –
Soflens One Day Bausch & Lomb HEMA, NVP 65 Hilafilcon-A
Softlens 66 Bausch & Lomb HEMA, VP 66 Alphafilcon-A
FDA Group III (<50% EWC <0.2 ionic content)
Accusoft Ophthalmos HEMA, PVP, MAA 47 Droxifilcon-A
Comfort Flex Capital Contact Lens HEMA, BMA, MAA 43 Deltafilcon-A
Durasoft 2 CIBA Vision HEMA, EEMA, MAA 38 Phemefilcon-A
Soft Mate II CIBA Vision HEMA, DAA, MAA 45 Bufilcon-A
FDA Group IV (>50% EWC >0.2 ionic content)
Acuvue Johnson & Johnson HEMA, MAA 58 Etafilcon-A
Durasoft 3 CIBA Vision HEMA, EEMA, MAA 55 Phemefilcon-A
Focus 1–2 Week CIBA Vision HEMA, PVP, MAA 55 Vifilcon-A
Focus Monthly CIBA Vision HEMA, PVP, MAA 55 Vifilcon-A
Frequency 55 Coopervision HEMA, MAA 55 Methafilcon-A
Hydrasoft Coopervision HEMA, MAA 55 Methafilcon-A
Hydrocurve II/3 CIBA Vision HEMA, DAA, MAA 55 Bufilcon-A
1 Day Acuvue Johnson & Johnson HEMA, MAA 58 Etafilcon-A
Permalens CIBA Vision HEMA, VP, MAA 71 Perfilcon-A
Softcon CIBA Vision HEMA, PVP, MAA 55 Vifilcon-A
Surevue Johnson & Johnson HEMA, MAA 58 Etafilcon-A
Ultraflex 55 Coopervision HEMA, MAA 55 Ocufilcon-D
HEMA, 2-hydroxyethyl methacrylate; VP, N-vinyl pyrrolidone; PVP, polyvinyl pyrrolidone (i.e., graft copolymer); MAA, methacrylic acid; MMA, methyl methacrylate; BMA, butyl
(probably isobutyl) methacrylate; AMA, alkyl methacrylate; CMA, cyclohexyl methacrylate; EEMA, ethoxyethyl methacrylate; DMA, N,N-dimethyl acrylamide; DAA, diacetone,
acrylamide; GMA, glycidyl, methacrylate; GlyMA, glyceryl, methacrylate; VA, vinyl acetate.
USAN, United States Adopted Name Council. Many USAN equivalents exist: for example, Hefilcon (Unilens, Miracon); Deltafilcon (Amsoft, Aquasoft, Aquasight, Metrosoft, Soft
Form, Softics, Softflow, Softact); Lidofilcon (CV 70, Genesis 4, Hydrosight 70, Q&E 70, Lubrisof. PDC 70, N&N 70); Tefilcon (Cibathin, Torisoft, Softint, Bisoft); Metafilcon
(Kontur, Metro 55, Biomedics 55, Mediflex 55, Omniflex 55); Polymacon (CustomEyes 38, Vesoft, Versaflex, Synsoft, Cellusoft). Polymacon has become used as a generic term
for polyHEMA and Lidofilcon for NVP-MMA copolymers. The SoftLens 2000 database (adp Consultancy, Bristol, UK) provides clinically relevant information and brand equivalents
on soft lenses in various modalities. Reprinted with permission from Efron, N.; Maldonado-Codina, C. In Contact Lens Practice, 2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/
Elsevier: Maryland Heights, MO, 2010; pp 78–79.
are packaged in ‘buffered saline with povidone.’ Povidone is there is an upper limit to how much oxygen permeability can
another name for PVP. PVP is quite polar and it is likely to be be attained simply by increasing the EWC of conventional
relatively strongly attracted to the etafilcon material, poten- hydrogel materials. A hydrogel with a theoretical EWC of
tially providing a mechanism for its retention on the lens 90% and a central thickness of 0.1 mm would have an oxygen
surface. The persistence of the PVP at the lens surface during transmissibility in the region of 60 Barrer per centimeter which
wear has been verified by Ross et al.29 who have also described still falls far short of that required to avoid additional overnight
the PVP as being in a predominantly ‘looped structure’ across corneal edema. Such a lens would need to be in the region of
the lens surface. 0.06 mm thickness which is unrealistic both from a man-
PVP decreases the coefficient of friction of the lens surface ufacturing and a clinical point of view.32
compared to its original counterpart. These changes are thought
to improve comfort by reducing lens–lid interaction on blinking 6.633.4.2. The Challenge of Incorporating Silicone into
or, in much the same way as the Focus Dailies lens, by mim- Hydrogel Materials
icking mucin found naturally in the tear film.
The new SofLens daily disposable lens is modified by As reducing the thickness of lenses made from conventional
the adsorption of Tetronic 1107 – a hydrophilic surface-active hydrogels was not an option for achieving success in extended
polymer composed of ethylene oxide/propylene oxide block wear, polymer scientists had to come up with an altogether
copolymer – on to the lens surface. The Tetronic at the surface new kind of material. That material was silicone. Incorporating
lowers the coefficient of friction of the lens but it has been silicone into contact lens materials was not a new concept
shown to be progressively lost from the surface during wear.29 when scientists began trying to produce silicone hydrogels.
It is likely, therefore, that the Tetronic is held by weak forces at Indeed, the first material to be used in contact lenses was
the lens surface, which would explain the least in-eye persis- silicone dioxide (glass). Additionally, silicone rubber (polydi-
tence of the three ‘enhanced’ lenses.29 methyl siloxane, PDMS) (Figure 7) has been used with limited
success as a contact lens material in the form of silicone elasto-
mer lenses. These lenses have not become popular mainly
6.633.4. Silicone Hydrogel Contact Lens Materials because of lens tightening and surface wettability problems
(PDMS is extremely hydrophobic).33 PDMS has an oxygen
6.633.4.1. The Drive for Increased Corneal Oxygenation
permeability in the region of 600 Barrer but is unwettable by
When Holden and Mertz30 defined the critical oxygen levels in tears, deposits high degrees of lipid, and needs to be surface
order to avoid corneal edema for daily and extended wear, they treated. Surface treatments of silicone elastomer lenses have
concluded that 24 Barrer per centimeter was the oxygen trans- not been particularly successful in the past because Si–O chains
missibility required for daily wear and 87 Barrer per centimeter have a tendency to rotate very easily and any hydrophilic parts
was that required for overnight wear. These values were reeval- of a newly treated surface tend to disappear inside the polymer.
uated by Harvitt and Bonanno31 who found that the minimum Silicon, however, has been very successfully incorporated
oxygen transmissibility required to avoid anoxia throughout into rigid lens materials, and it was this development which
the entire cornea was 35 Barrer per centimeter for the open eye has proven to be a key milestone in the subsequent develop-
and 125 Barrer per centimeter for the closed eye. ment of silicone hydrogel materials. The first siloxane-based
From inspection of the relationship between the EWC and rigid lens material merged the properties of MMA with
the Dk of conventional hydrogels (Figure 4), it is obvious that the increased oxygen performance of silicone rubber.34,35
CH3 CH2 CH
CH2 C O
C O C O
O NH
CH2 CH2
CH2 CH2
CH3 CH2 CH3 CH3 CH2 CH3

CH3
CH3 Si O Si O Si CH3 CH3 Si O Si O Si CH3
O Si
n CH3 O CH3 CH3 O CH3
CH3 CH3 Si CH3 CH3 Si CH3
CH3 CH3
PDMS TRIS TPVC
Figure 7 Silicone-based materials. PDMS, polydimethyl siloxane; TRIS, tris(trimethylsiloxy)-methacryloxy-propylsilane; TPVC, carbamate-substituted
TRIS. Adapted from Maldonado-Codina, M.; Efron, N. In Contact Lens Practice, 2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/Elsevier: Maryland
Heights, MO, 2010; p 79.
The resultant siloxymethacrylate monomer was tris(trimethyl- 6.633.4.5. Material Modulus of Elasticity
siloxy)-methacryloxy-propylsilane (Figure 7) and is more
Another important difference between these materials and
commonly referred to as TRIS.
conventional hydrogels is that they have significantly greater
The patent literature shows that combining silicone with
elastic moduli. Such mechanical characteristics mean that
conventional hydrogel monomers has been a goal for polymer
the lenses are easy to handle but have also been implicated
scientists since the late 1970s. The biggest obstacle to this
in the etiology of a number of clinical complications.38 These
approach, however, is that silicone is hydrophobic and poorly
include higher incidences of superficial epithelial arcuate
miscible with hydrophilic monomers resulting in opaque,
lesions (SEALs), mucin balls, and contact lens papillary con-
phase-separated materials. In order to solve this problem, two
junctivitis, especially with continuous wear of these lenses.39
main approaches have been utilized.11 The first approach
The stiffness of the material may contribute to the mechanical
involves the insertion of polar groups into the TRIS molecule
irritation of the lens rubbing against the conjunctiva of the
in order to aid its miscibility with hydrophilic monomers.36,37
upper eyelid producing a localized response.
The second approach is that of utilizing macromers. These
are large monomers formed by preassembly of structural units
that are designed to bestow particular properties on the final 6.633.4.6. Lens Edge Design
polymer.11 Figure 4 demonstrates the relationship between
The design of the lens, and in particular the edges, may also
Dk and EWC for silicone-containing hydrogels based on TRIS,
impact ocular compatibility. It has also been suggested that the
highlighting the benefits of increased oxygen performance.
design of the lens edge in conjunction with the mechanical
properties of silicone hydrogel lenses may be responsible
6.633.4.3. The Launch of Silicone Hydrogel Lenses for increased conjunctival staining and conjunctival epithelial
flaps observed with these lenses.40 A knife-point edge or chisel-
The first two silicone hydrogels were launched in the late 1990s –
shaped edge may cause more conjunctival staining and flap
the PureVision lens (Bausch & Lomb) and the Focus Night & Day
formation than a round edge by ‘carving’ into the conjunctival
lens (CIBA Vision). Both were licensed for 30 days of continuous
tissue.41 It has been proposed that certain edge designs incor-
wear. The PureVision lens (balafilcon A) has an EWC of 36%
porating localized increases in posterior edge lift, reduced
and an oxygen transmissibility of 110 Barrer per centimeter (at
peripheral thickness, or peripheral channels may reduce the
3.00D). The exact compositions of these materials are proprie-
pressure on the conjunctiva.41
tary but the USAN-registered components of the balfilcon A
material show that it is based on a carbamate-substituted TRIS-
based material known as TPVC (Figure 7). The TPVC is then 6.633.4.7. ‘Second Generation’ Silicone Hydrogel Lenses
copolymerized with NVP to form the balafilcon material.
The Focus Night & Day lens (lotrafilcon A) has an EWC of In an attempt to improve on the problems encountered with the
24% and an oxygen transmissibility of 175 Barrer per centime- early silicone hydrogels, manufacturers have engaged in a pro-
ter (at 3.00D) and is said to be ‘biphasic.’ Tighe11 describes gram of research aimed at manufacturing silicone hydrogel
the lens as being a fluoroether macromer copolymerized with lenses with improved mechanical and surface characteristics.
TRIS and DMA (N,N-dimethyl acrylamide) in the presence This has resulted in the gradual emergence of ‘second generation’
of a diluent. Its biphasic structure means that oxygen and silicone hydrogel lenses such as Acuvue Advance, Acuvue Oasys,
water permeability channels are not reliant on each other. TruEye, Avaira, Biofinity, and Clariti. Table 2 compares the prop-
The silicone-containing phase allows passage of oxygen while erties of all the silicone hydrogel lenses currently on the market.
the water phase primarily allows the lens to move. The main advantage of these ‘second generation’ silicone
hydrogels compared to the early silicone hydrogels is that they
have increased water contents and reduced moduli, and they
6.633.4.4. Surface Treatments do not need to be surface treated. The mechanical and surface
Without further treatment both of these lenses would be properties can be thought of as being ‘in between’ those of
unsuitable for wear because of the fact that the resultant mate- conventional hydrogels and the early silicone hydrogels.
rial surfaces are very hydrophobic. In order to overcome this Results of clinical studies indicate that there may be a lower
problem, both lenses are surface treated using gas plasma incidence of contact lens-induced papillary conjunctivitis
techniques. High-energy gases or gas mixtures (the plasma) (CLPC) with these lenses.42
are used to modify the lens surface properties without chang-
ing the bulk properties. The result for the balafilcon lens is that
6.633.4.8. Optimizing Surface Characteristics
surface wettability is gained via plasma oxidation which pro-
duces glassy silicate islands on the lens surface. Some of the lenses in Table 2 are based on materials contain-
The lotrafilcon lens is coated with a dense 25-nm-thick ing TRIS-like components. Acuvue Advance and Acuvue Oasys
coating. Both resultant surfaces have low molecular mobility are on the basis of Tanaka’s original patent (following it’s
which minimizes the migration of hydrophobic silicone groups expiration after 25 years) using a modified TRIS molecule, a
to the surface. However, despite these surface modifications, silicone macromer, and hydrophilic monomers such as HEMA
wettability problems with these lenses have been reported. It is and DMA. Alcohol is used as a solvent to aid the miscibility of
generally accepted that these lenses have inferior wettability these ingredients and is then extracted following polymeriza-
compared to conventional hydrogels which occurs as a result tion. High-molecular-weight PVP is the internal wetting agent
of the hydrophobic interaction of silicone with the tear film. (the ‘Hydraclear’) used in these lenses, which is entangled and
Development of Contact Lenses from a Biomaterial Point of View – Materials, Manufacture, and Clinical Application
Table 2 Currently available silicone hydrogel lenses
Brand name PureVision Focus Night & O2 Optix Avaira Biofinity Acuvue Advance Acuvue Oasys TruEye PremiO Clariti
Day
Manufacturer Bausch & CIBA Vision CIBA Vision CooperVision CooperVision Johnson & Johnson & Johnson & Menicon Sauflon
Lomb Johnson Johnson Johnson
USANa Balafilcon A Lotrafilcon A Lotrafilcon B Enfilcon A Comfilcon A Galyfilcon A Senofilcon A Narafilcon A Asmofilcon A –
Water content 36 24 33 46 48 47 38 46 40 58
(%)
Oxygen 91 140 110 100 128 60 103 100 129 60
permeability
(Barrers)b
Modulus 1.50 1.52 1.00 0.50 0.75 0.43 0.72 0.66 0.91 0.50
(MPa)
Surface Plasma Plasma coating Plasma None (internal None (internal None (internal None (internal None (internal Plasma None
treatment oxidation coating wetting wetting wetting agent, wetting agent, wetting agent, treatment (wetting
agent, agent, PVP) PVP) PVP) process not
undisclosed) undisclosed) disclosed)
Principal NVP, TPVC, DMA, TRIS, DMA, TRIS, NVP, VMA, NVP, VMA, MPDMS, DMA, MPDMS, DMA, MPDMS, DMA, SIMA, SIA, Not disclosed
monomersc NCVE, siloxane siloxane IBM, TAIC, IBM, TAIC, HEMA, EGDMA, HEMA, siloxane HEMA, siloxane DMA,
PBVC monomer monomer M3U, M3U, siloxane macromer, macromer, pyrrolidone
FM0411M, FM0411M, macromer, PVP TEGDMA, PVP TEGDMA, PVP derivative
HOB HOB
PVP, polyvinyl pyrrolidone; MPDMS, monofunctional polydimethylsiloxane; DMA, N,M-dimethylacrylamide; HEMA, hydroxyethyl methacrylate; EGDMA, ethyleneglycol dimethacrylate; TEGDMA, tetraethyleneglycol dimethacrylate; TRIS, trimethyl
siloxysilyl; NVP, N-vinyl pyrrolidone; TPVC, tris-(trimethyl siloxysilyl) propylvinyl carbamate; NCVE, N-carboxyvinyl ester; PBVC, poly(dimethysiloxy) di (silylbutanol) bis (vinyl carbamate); VMA, N-vinyl-N-methylacetamide; IBM, isobornyl
methacrylate; TAIC, 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione; M3U, bis(methacryloyloxyethyl iminocarboxy ethyloxypropyl)-poly(dimethylsiloxane)-poly(trifluoropropylmethylsiloxane)-poly(methoxy-poly[ethyleneglycol]
propylmethylsiloxane); FM0411M, methacryloyloxyethyl iminocarboxyethyloxypropyl-poly(dimethylsiloxy)-butyldimethylsilane; HOB, 2-hydroxybutyl methacrylate; SIMA, siloxanyl methacrylate; SIA, siloxanyl acrylate.
a
United States Adopted Name.
b
Manufacturer-reported values.
c
Partly from Jones, L.; Dumbleton, K. Contact lens fitting today. Silicone hydrogels Part 1: Technological developments. Optometry Today, November 18, 2005, 23–29. Reprinted with permission from Efron, N.; Maldonado-Codina, C. In Contact Lens
Practice, 2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/Elsevier: Maryland Heights, MO, 2010; p 81.
529
therefore ‘entrapped’ within the lens matrix, and allows them and fully automated manufacturing lines, depending on the
to be manufactured without requiring a surface treatment.43,44 capital budget or skill levels available. Even with the use
The PVP essentially works by shielding the silicone from the of automation, however, the number and variability of man-
tear film at the lens interface. ufacturing steps, which are necessary for lathe cutting, means
The Biofinity lens (comfilcon A) is not based on TRIS that manufacturing soft lenses using this technology is necessar-
chemistry. It comprises solely silicon-containing macromers ily more expensive than that using spin casting or cast molding.
and requires no surface treatment or wetting agent. The Therefore, lathe cutting is generally reserved for the produc-
patents surrounding the material refer to a monofunctional tion of custom-ordered or extreme range lenses that contain
macromer (containing only one double bond which takes design features not amenable to mass production, such as lenses
part in the polymerization process) being combined with of high spherical power and/or high toric power, and more
another rubber-like siloxy macromer resulting in a material recently, aberration-correcting soft lenses for keratoconus.47
with much longer chains (higher molecular weight) compared The raw xerogel is supplied to the lens manufacturer in the
to the other silicone hydrogels.45,46 The patents also discuss form of ‘rods’ or ‘buttons.’ A rod is a solid cylindrical piece of
other hydrophilic monomers which are presumably the key to xerogel, about 16 mm in diameter and 400 mm long. The rod is
why these materials do not need to be surface treated. The then sliced, tangentially to the long axis, into buttons about
material chemistry of this lens provides a higher than expected 10 mm thick. More commonly, the xerogels are fabricated and
oxygen transmissibility for its water content. The introduction supplied in button form. When this occurs, buttons have usu-
of these ‘second generation’ lenses has also seen a significant ally been pretrimmed to a industry standard size so that it can
rise in the number of silicone hydrogel lenses being prescribed be machined in most of the available lathes.
on a daily wear basis. The button is first secured to a back surface lathe in a
clamp or ‘collet,’ and this assembly is set spinning at a high
rate (typically 8000–12000 rpm) about its central axis.
6.633.5. Classification of Soft Contact Lens Materials A diamond-tipped tool cuts the posterior surface lens shape
into the button. A second diamond tool advances from the side
There are three main classification systems for soft contact lens to reduce the diameter to the required size. The surface is
materials. Two are well established: the UK Association of rendered smooth by either fine machining or polishing. Mod-
Contact Lens Manufacturers (ACLM) classification system ern sophisticated lathes are capable of cutting xerogel surfaces
and the US Food and Drug (FDA) classification system. A to a tolerance of 8–15 nm. Such smooth surface finishing pre-
third classification system has been put forward in a British cludes the need for polishing and is preferred when nonspherical
and International Standard.8,9 These classification systems are surface geometries are being generated. This approach also serves
expanded upon in Appendix A. to preserve the consistency of one surface to the next. The dimen-
sions of the lathed surface are calculated to allow for eventual
expansion when the xerogel is later hydrated.
6.633.6. Soft Contact Lens Manufacture The button is removed from the collet and the cut posterior
surface of the button is mounted onto a support tool of a front
Three techniques can be employed to manufacture soft contact surface lathe, using low melting point wax. It is essential during
lenses – lathe cutting, spin casting, and cast molding. As medi- this process that the button is mounted and fixed in an abso-
cal devices that rest against the highly sensitive eyeball, contact lutely concentric and level aspect to the support tool in order to
lenses need to be of the highest quality in terms of their minimize unwanted prism being introduced by the front sur-
physical construction. As devices that correct optical defocus, face cutting. A diamond-tipped tool cuts the anterior surface
the optical quality of contact lenses must also be of the highest down to the required thickness, and the surface is smoothed.
order. At the same time, it must be recognized that companies The most advanced lathes now offer ‘W’ axis cutting options
will only manufacture contact lenses if they are profitable; the that can generate rotationally nonsymmetric surfaces while the
dominant forces in the market dictate that these high-quality primary front surface is being cut. Polishing tools may be used
products must be delivered at minimal cost, and one conse- to smooth the lens edge, although some advanced lathes obvi-
quence of this is a simplification of lens parameters to stream- ate this step.
line the high-volume process. After inspecting and measuring all relevant dry lens para-
A key requisite of any technology employed to manufacture meters, the lens is hydrated in normal, unpreserved saline until
a medical appliance is that the final product is safe, predictable, it is fully equilibrated and impurities have been extracted. The
and of high quality, so that it meets the intended need. The hydrated lens is reinspected for final wet parameter confor-
three technologies discussed below have been developed to mity, sealed in small glass vials and autoclaved at 120 C for
meet these requirements. 15 min to effect sterilization. Advances in lathing technology
and computer-controlled processing have led to the develop-
ment of semiautomatic systems whereby stacks of buttons
6.633.6.1. Lathe Cutting
are automatically fed into lathes; however, even this technol-
This process essentially involves the use of a special contact ogy cannot match the mass-production capabilities of cast
lens lathe to cut an anhydrous cylindrical button of material molding.
(xerogel) into the required shape, and then hydrating this to Figure 8 is a schematic flow diagram illustrating the pro-
form the finished soft lens. Lathe manufacture ranges from cess of manufacturing a soft contact lens using lathe cutting
labor-intensive, manual-based cutting systems to sophisticated technology.
Polymer
button
Back Button Front
surface transferred to surface
lathe front surface lathe
Polymer lathe
rod
1 2 3 4
Hydrated lens Anhydrous lens

is inspected Lens hydrated is inspected
in saline (and swelling)
Anhydrous
lens edge
polishing
8 7 6 5
Lens is inserted
into glass vial Glass vial containing
Glass vial and lens
containing saline lens is sealed and
are autoclaved
labeled
9 10
Vials containing
lenses are
11 12
despatched
individually
Figure 8 The process of manufacturing a soft contact lens by lathe cutting. (1) The dry polymer is supplied as a rod or button. (2) A polymer
button is placed on a lathe; the button spins and a diamond knife is advanced toward the button to generate the lens back surface. (3) The button is
released from the back surface lathe. (4) The button is mounted on a front surface lathe with adhesive wax; the button spins and a diamond knife
is advanced toward the button to generate the lens front surface. (5) The dry lens is removed from the lathe and the edges are polished. (6) The
lens is inspected at 10 magnification. (7) The dry lens is placed in saline to hydrate the lens, which swells to its final soft lens form. (8) The
hydrated soft lens is inspected at 10 magnification. (9) The soft lens is inserted into a glass vial containing saline. (10) The glass vial is sealed
and labeled. (11) The sealed glass vial containing the lens is sterilized in an autoclave. (12) The individual glass vials are despatched. Reprinted
with permission from Efron, N.; Newman, S. In Contact Lens Practice, 2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/Elsevier: Maryland Heights,
MO, 2010; p 87.
6.633.6.2. Spin Casting

In this process, a convex ‘male-shaped’ stainless steel tool, or
‘insert,’ is produced on a high-precision engineering lathe and
lapped to provide an accurate surface that matches the dry
dimensions of the proposed anterior surface of the contact lens
(Figure 9). Modern nonferrous materials are also suitable for
producing the mold tool and these materials can be generated on
‘nano-accurate’ single point turning lathes. These lathes can cut
mold tools to a surface finish which renders polishing unneces-
sary. The final surface shape of the master mold tool is verified
using interferometry or other similar noncontact measuring
methods. Any given tool is used to make millions of molds.
The steel tool is impressed against heated liquid polypro- Figure 9 A male-shaped stainless steel tool being cut to shape using a
pylene or polyvinyl chloride (PVC), which then cools and sets high precision lathe. This tool will be used to form female molds.
to form a solid plastic concave female mold. A series of about Reprinted with permission from Efron, N.; Newman, S. In Contact Lens
eight tools is used to produce eight molds simultaneously. The Practice, 2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/Elsevier:
molding methods and tooling used must be very accurate in Maryland Heights, MO, 2010; p 89.
order to preserve the concentricity of the resultant plastic part. disposable lenses) with higher numbers of tools. Some
Any molding run out will create unwanted prism in the lens machines can successfully carry as high as 36 cavities (18
during the spinning process. This sort of injection cast molding males and 18 females) in one mold base. Molding parameters,
is generally conducted in a controlled environment. It is imper- tool accuracy, cooling, and balancing are critical if this is to be
ative for a spin cast manufacturing process to control the level successful. The manufacturer will seek a balance between output
of potential contaminants to a minimum as it is an open and accuracy with the molding process.
molding system. Cast molding generally takes place in a continuous, auto-
The xerogel lens form is created by pouring liquid mono- mated production line (Figure 12). Monomer in liquid form is
mers into the concave molds, which spin at a high rate about introduced into a concave female mold, which defines the
the central mold axis. shape of the lens front surface. An ultraviolet-transparent
This spinning takes place in a controlled atmosphere of male mold is mated to the female mold and the two are
carbon dioxide or similar oxygen deprived atmosphere. This clamped together in a carefully controlled environment.
is necessary as the spin mold is an open system and thus The contact lens edge is formed when the two sides of the
exposes one surface of the lens (posterior) to air as it is being mold come together. There is considerable science and art in
cured. Oxygen in air is a natural scavenger of the initiator and the control of the polymerization process and the pressure that
will ultimately inhibit the polymerization process. is applied to the mold to form the lens. A crucial aspect of this
The speed of rotation, combined with both the mold tool process is to arrange for the excess polymer (so-called ‘flash’) to
shape and monomer dose, ultimately determines the final lens be squeezed out while leaving the edge intact.
parameters. The shape of the back surface is governed by Once the polymer is encapsulated in the mold, it is ‘cured’– a
centrifugal force generated by the rate of spin of the mold, process in which the assembled molds are exposed to either UV
surface tension and friction forces between the mold and poly- light or thermal radiation, or a combination of both, to effect
mer, and the effects of gravity. A greater speed of rotation of the polymerization so as to form the dry contact lens. Most cast-
mold will result in more polymer mass being shifted toward molding processes are designed so that when the dry lens is
the lens periphery, and more negative lens power. Because of removed from the mold there is no need to polish the edge. The
this system of manufacture, certain process controls such as molds are disassembled and discarded, and the lens that is
monomer dosing must be more accurate than those found in released from the molds – still in rigid form – is hydrated in saline.
full cast molding of contact lenses. Inspection is undertaken either manually (Figure 13) or
As the mold spin rate stabilizes, ultraviolet radiation and/or using automated video-based computer-controlled image
heat is introduced to initiate polymerization. The lens is removed analysis. Finally, the lens blister packs are sealed, labeled
from the mold, and the mold is discarded. Certain spinning (Figure 14), autoclaved, and packaged in boxes. Figure 15 is
processes hydrate the lens in the original plastic mold, which is a flow diagram of the cast-molding process.
never removed. Such a process has been proven advantageous It should be recognized that the above descriptions are highly
and cost-effective for the mass production of daily lenses. simplified accounts of sophisticated engineering processes. Vari-
Other spinning systems still require that the edges of the ous manufacturers have introduced a number of unique varia-
lens are polished and that the lens be inspected, hydrated, tions, such as wet-state polymerization, the employment of
reinspected, packaged, and autoclaved. Spin casting can pro- reusable glass molds,48 and use of the male half of the mold
duce a much higher output volume than lathe cutting, and in for final lens packaging. Also, toric and bifocal lenses can be
the latest systems, can match the high volume of lenses that can manufactured using either spin-casting or cast-molding technol-
be produced by cast molding. The primary restriction of spin ogy by engineering the master tools to contain the desired lens
cast manufacture lies in its inability to generate a fully formed forms; these design elements will then be faithfully transposed to
edge from the posterior to anterior surface; however, sophisti- the molds and then to the final lens.
cated design modeling, combined with accurate tooling, has
largely mitigated this limitation. The process of spin casting is
6.633.6.4. Reproducibility and Quality of Mass-Produced
illustrated in Figure 10.
Lenses
Practitioners who prescribe lenses, and patients who wear
6.633.6.3. Cast Molding
lenses, need to be assured of the reproducibility of lenses that
Cast molding has become the dominant technology in high- have been manufactured using mass-production techniques.
volume lens manufacture. As with spin casting, a series of highly Young et al.49 determined the reproducibility of 24 lenses in
polished steel tools is used to fabricate polypropylene molds; three lens powers (1.00D, 3.00D, and 6.00D) of eight
however, matching male and female molds are required for cast common frequent replacement spherical soft contact lens types.
molding. Again, modern nonferrous materials are suitable for They found that the mean power of all the lenses was higher
producing the mold tool and can be generated to extremely fine than their labeled powers, although all were within the tolerance
levels of accuracy and surface finish. These master tools are used ranges. Reproducibility was observed to be worse for all lenses at
to make millions of male and female molds (Figure 11). higher powers. All but two lens types had mean diameters within
The variations found in different manufacturing facilities tolerance. A slight reduction of optical quality at high powers
around the world, however, attest to significant development was noted. Measures of back optic zone radius, center thickness,
in challenging this norm. Modern molding machines can and overall diameter showed reasonably good repeatability.
create reproducible results (a critical requirement for the In a similar study conducted on three brands of daily
high-volume production of contact lenses, particularly daily disposable contact lenses, Efron et al.50 found that 450 lenses
1 2 3 4
Female Monomers
mold introduced
Ultraviolet radiation
into spinning
mold
Female mold
Male
tool
Hydrated lens Lens hydrated Anhydrous lens

is inspected in saline (and swelling) is inspected
Anhydrous lens is
removed from mold
and the edge may be
polished
8 7 6 5
Lens is inserted Blister pack containing Blister pack and lens

into blister pack lens is sealed and are autoclaved
containing saline labeled
9 10
Blister packs containing
11 12
lenses are boxed and
despatched
Figure 10 The process of manufacturing a soft contact lens by spin casting. (1) A male tool is machined from stainless steel; the contour of the
tool head will define the shape of the anterior lens surface. The same tool is used to make millions of molds. (2) A female mold is made by
pressing the male tool into molten polypropylene, which cools and sets. (3) The female mold is mounted, with the concavity facing upward, in a
spindle that spins about the lens axis, and liquid monomers are introduced into the spinning mold. (4) The monomers in the spinning mold are
irradiated with ultraviolet light to initiate lens polymerization. (5) The dry lens is removed from the mold, the lens edge is polished, and the mold is
discarded. (6) The edge of the dry lens is inspected at 10 magnification. (7) The dry lens is placed in saline, which hydrates the lens, causing it to
swell to its final soft lens form. (8) The hydrated soft lens is inspected at 10 magnification. (9) The soft lens is inserted into a blister pack
containing saline. (10) The blister pack is sealed with a special foil, and a label is stuck onto this. (11) The sealed blister pack containing the lens
is sterilized in an autoclave. (12) The individual blister packs are inserted into packages, typically in multiples of either three or six lenses.
Reprinted with permission from Efron, N.; Newman, S. In Contact Lens Practice, 2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/Elsevier:
Maryland Heights, MO, 2010; p 89.
of 3.00D in power displayed an overall high degree of often be seen on the surface of soft lenses that have been
accuracy and reproducibility. They concluded that, with a manufactured by lathe cutting; these ‘lathe marks’ are often
single inconsequential exception, all measured parameters visible under high magnification using the slit-lamp biomicro-
were found to fall well within clinically acceptable limits for scope. Using atomic force microscopy, Bhatia et al.55 observed
providing wearers of these lenses with consistent vision and fit. that the surface of unused cast-molded lenses varied from
Efron and Veys51 examined the quality of three types of early smooth to rough with surface features unique to the polymers
generation disposable lenses and observed a high prevalence of and manufacturing process.
nicks, tears, roughness, and blemishes. At the time, other Maldonado-Codina and Efron56 investigated the impact of
authors reported similar findings.52–54 These studies accorded manufacturing method and material composition on the surface
a valuable service to the contact lens industry in the early 1990s characteristics of five types of hydrogel contact lenses: three
as they focused attention on the importance of the quality of pHEMA lenses, each manufactured by a different technique,
mass-produced lenses, especially edge quality. Advances in namely, lathing, spin casting, and cast molding, a HEMA/MAA
cast-molding manufacturing technology over the past two dec- cast-molded lens, and a HEMA/glycerol methacrylate cast-
ades, fuelled by the attention drawn to the above issues, have molded lens. Front and back lens surfaces were examined using
led to a substantial overall improvement in lens quality. scanning electron microscopy (SEM) and atomic force micros-
At a microscopic, subclinical level, it can be observed that copy (AFM). The surfaces of the lathed lenses were covered in
different manufacturing techniques can have a significant lathing/polishing marks. In general, at a microscopic level, the
effect on the finished lens surface. Fine concentric rings can anterior surface appeared rougher. All three cast-molded lenses
Figure 13 Manual inspection of contact lens quality. Reprinted with

permission from Efron, N.; Newman, S. In Contact Lens Practice,
2nd ed.; Efron, N., Ed.; Butterworth-Heinemann/Elsevier: Maryland
Heights, MO, 2010; p 90.
Figure 11 Polypropylene molds being prepared for lens for casting.
Figure 12 Automated production line for cast-molding soft contact

lenses.
Figure 14 Automated contact lens labeling. Reprinted with
permission from Efron, N.; Newman, S. In Contact Lens Practice, 2nd ed.;
had more processing debris than the lathed and spun-cast
Efron, N., Ed.; Butterworth-Heinemann/Elsevier: Maryland Heights, MO,
pHEMA lenses. Overall, the surfaces of the lathed lens were 2010; p 90.
‘rougher’ than those of the cast-molded lens. Maldonado-
Codina and Efron56 concluded that surface topographies of
hydrogel contact lenses are dependent on method of manufac- and Efron.56 Manufacturing method was found to have only a
ture. They also noted that cast-molded lenses are associated with minor effect on the quality and stability of the PLTF in HEMA
apparently ‘stickier’ surfaces, which may be indicative of surface lenses. The authors concluded that PLTF structure is likely
degradation during the manufacturing process. to be more related to material and patient characteristics
Maldonado-Codina and Efron57 measured high- and low- than manufacturing method.
contrast visual acuity, and the level of protein deposition,
in patients wearing HEMA lenses made by three manufacturing
methods. They found that spun-cast HEMA lenses deposited 6.633.7. Clinical Ramifications of Polymer and
less protein than cast-molded or lathed HEMA lenses; however, Manufacturing Developments
the differences in the amount of protein deposited did not
affect visual function. As with all developments in the field of biomaterials, tech-
The impact of manufacturing method on the PLTF of soft nological innovations and improvements are ultimately
HEMA contact lenses was also investigated by Maldonado-Codina driven by the needs of clinicians working in the specific fields
1 2 3 4
Female mold Male mold
Monomers
introduced Male mold
Male Female
tool tool into mold
Female mold Female mold
Excess
polymer
Ultraviolet radiation
squeezed
Anhydrous lens is
Final stages as out
removed from mold
per steps 6–12
for spin casting
7 6 5
Figure 15 The process of manufacturing a soft contact lens by cast molding. (1) Male and female tools are machined from stainless steel; the contour
of the male tool head will define the shape of the anterior lens surface, and the contour of the female tool head will define the shape of the posterior
lens surface. The same tools are used to make millions of molds. (2) Male and female molds are made by pressing the tools into molten polypropylene,
which cools and sets. (3) The female mold is mounted on a conveyer belt, with the concavity facing upward, and liquid monomers are introduced
into the concavity. (4) The male mold is registered over the female mold and the two molds are clipped together. (5) Excess polymer is squeezed
out from the sides of the mold. (6) The monomers inside the mold assembly are irradiated with ultraviolet light to initiate lens polymerization.
(7) The dry lens is removed from the mold and the molds are discarded. The final stages of lens production are essentially the same as for spin
casting, which is illustrated in steps 6–12 in Figure 10. Reprinted with permission from Efron, N.; Newman, S. In Contact Lens Practice, 2nd ed.;
Efron, N., Ed.; Butterworth-Heinemann/Elsevier: Maryland Heights, MO, 2010; p 91.
to which the biomaterials relate. In the early stages of amblyopic, acted as a control. Thus, any difference between
the development of soft contact lenses (i.e., throughout the the two eyes could be attributed to the long-term effects of soft
1970s and 1980s), two critical problems adversely impacted lens extended wear.
upon the biocompatibility of contact lenses: insufficient oxy- The lens-wearing eye showed a 14.8% reduction in epithe-
genation of the cornea to sustain normal metabolic processes lial oxygen uptake (p < 0.001), a 5.6% reduction in epithelial
during lens wear, and problems relating to the buildup of thickness (p < 0.05), a 2.3% reduction in stromal thickness
deposits on the lens (and absorbed into the lens matrix) (p < 0.05), the induction of epithelial microcysts, and a
over time. 22.0% increase in endothelial polymegethism (p < 0.001).
This section will provide an overview of ramifications of Endothelial cell density was unaffected by extended lens
developments in polymer chemistry and manufacturing tech- wear. No interocular differences in any of these physiological
nology that have essentially solved the problems of poor cor- characteristics were found in a matched control group of ani-
neal oxygenation and long-term deposit buildup. Although sometropic and amblyopic subjects who did not wear contact
evidence had slowly been accumulating in the ophthalmic lenses, which validated the use of the contralateral eye as a
literature throughout the 1970s and 1980s of the imperative control in this experiment.
of developing soft lenses that could alleviate hypoxia and avoid The patients ceased lens wear for up to 1 month and recovery
deposit formation, the definitive work to address this issue of corneal function was monitored during this period. Epithelial
was the celebrated 1985 report that became known as the oxygen uptake and thickness recovered within 33 days of lens
‘Gothenburg study.’58 This landmark publication is one of removal. The number of microcysts increased over the first
the most highly cited papers in the field of contact lenses. 7 days, but decreased thereafter; some microcysts were still pres-
It provided a clear rationale of the imperative of solving ent 33 days after lens removal. Recovery from stromal thinning
these two problems, and pointed toward the likely solutions. had not occurred after 33 days following lens removal. There
The Gothenburg study – so named because the research was was a slight reduction in polymegethism in some patients, but
undertaken in Gothenburg, Sweden – assessed the effects of overall this was not statistically significant. These findings estab-
long-term extended wear of soft contact lenses on the human lish (1) that the extended wear of hydrogel lenses induces
cornea. This was achieved by examining 27 patients who had significant changes in all layers of the cornea; (2) that lens
worn a high water content hydrogel contact lens in one eye wear suppresses aerobic epithelial metabolism, which may com-
only for an average of 62 29 months (mean standard devi- promise the epithelial barrier to infection; and (3) that changes
ation). The other eye, which was either emmetropic or to the stroma and endothelium are long lasting.
The authors of the Gothenburg study concluded – on the tear exchange have been investigated, such as (a) introducing
basis of the outcome a regression analysis of the data – that channels, patterns, or grooves in the posterior surface of the
lens-induced effects on corneal physiology can be minimized lens, to act as conduits of hydraulic flow;59,60 (b) designing
by fitting lenses that (1) are more frequently removed, (2) have lenses to facilitate a form of pumping action, whereby the lens
greater oxygen transmissibility, (3) are more regularly replaced, would move closer to, and further from, the plane of the
and (4) are more mobile on the eye.58 This conclusion became cornea; or (c) introducing fenestrations (small holes) in the
the blueprint for contact lens development over the next quar- lens.61 While theoretical models point toward an enhancement
ter of a century, and to this day remains the single most of postlens tear exchange using these strategies, practical solu-
important set of doctrines governing technological refinements tions remain elusive.
in the field.
The first requirement – that lenses should be more fre-
6.633.7.1. Polymer Developments: Enhanced Corneal
quently removed – was easily solved by advising those using
Oxygenation
lenses on an extended wear basis (i.e., wearing lenses continu-
ously day and night) of the imperative of wearing lenses con- Arguably, the question of corneal oxygenation has been the
tinuously for no more than 30 days. This now represents most important driver of technological developments in the
standard advice worldwide, and is entrenched in legislation contact lens field. In fact, this problem was signaled at the very
in the United States via directives from the FDA. In the early time a contact lens was fitted for the correction of myopia.
days of extended wear, it was thought that it might be possible This was in 1889; a 25-year-old medical student named
to use lenses on an extended wear basis indefinitely, but it was August Müller (1864–1949) submitted the results of his
gradually realized (and confirmed by the Gothenburg study) final year project, entitled ‘Brillenglüser und Hornhautlinsen’
that the longer lenses were worn continuously, the greater was (Spectacle Lenses and Cornea Lenses), to the University of Kiel
the adverse physiological impact. in Germany.62 As can be seen from Figure 16, Müller wore
The second requirement – that lenses have greater oxygen spectacles to correct high myopia.
transmissibility – was a far more difficult problem to address, In what must have been perceived as a bold and perhaps
as it pointed toward the need to develop new materials with dangerous experiment, Müller fitted himself with large, thick
an oxygen permeability approaching an order of magnitude glass lenses (known as ‘haptic’ lenses); however, he was only
greater than existed at the time of the Gothenburg study. The able to wear them for half an hour, and provided the following
answer to this was the development of silicone hydrogel mate- graphic description of his experience:
rials, as discussed in Section 6.633.4. The clinical ramification
of the introduction of these materials is discussed below in Gradually, about a quarter of an hour after insertion, a sensation of
Section 6.633.7. pressure and burning appeared, which could not be localized
exactly. After a further quarter of an hour, the sensation became so
The requirement that contact lenses should be more regu- agonizing that I had to remove the lenses. Upon their removal, the
larly replaced – the third edict of the Gothenburg study – violent pain immediately stopped and a short while after I could use
pointed toward the need to develop manufacturing processes the eyes again.
that would allow mass production of high-quality contact
lenses. The inventor of soft contact lenses, Otto Wichterle, Müller was so disappointed with the results of his experi-
had attempted to fabricate lenses using cast molding, but was ments that he gave up the idea of becoming an eye specialist
unhappy with the resultant quality of the lens edge, so he and went on to practice as an orthopedic surgeon.62
developed an alternative spin-casting technique.14 It was not This pioneering work signaled the beginning of the battle
until the mid-1980s that cast molding became commercially to develop contact lenses that could be worn comfortably
viable, and this heralded the development of regular replace- and continually for many hours. As it turned out, Müller was
ment disposable lenses. The cast-molding manufacturing pro-
cess has been discussed in Section 6.633.6.3, and clinical
impact of this technology is discussed in Section 6.633.7.
The fourth requirement of the Gothenburg study – that
lenses should be more mobile on the eye – relates to the
need to constantly flush out debris that accumulates behind a
contact lens during wear. At the time of the Gothenburg study,
increased lens mobility was the only strategy possible to
enhance tear exchange beneath the lens surface. However,
other strategies are possible, so this requirement, which has
yet to be solved, is perhaps better stated today as a need for
greater postlens tear exchange.
The requirement for a greater postlens tear exchange is
especially critical for overnight wear, when metabolic bypro-
ducts, tear-film components such as lipid and mucin, and
naturally desquamating epithelial cells accumulate in the post-
lens tear film and form a potential ‘breeding ground’ for micro-
organisms, leading to an increased risk of inflammation and
infection.25,26 Various strategies for increasing greater postlens Figure 16 August Müller.
entirely correct in ascribing the failure of his own lens-wearing the introduction of silicone hydrogel materials this century
experiments to “. . . a disturbance of nourishment of corneal has essentially solved this problem.
tissue.” Unlike all other tissues in the body, the cornea does not During the waking hours, silicone hydrogel lenses supply
contain blood vessels (so that it can remain optically transpar- the cornea with enough oxygen to avoid excessive edema.64
ent); therefore, in order to respire normally, it must obtain However, there is a small but significant minority of patients
oxygen directly from, and eliminate carbon dioxide directly who need or desire to sleep in lenses, due to the convenience of
to, the atmosphere. Although he did not know it at the time, being able to wake up, either in the morning or in the middle
Müller’s haptic lenses prevented this necessary exchange of of the night, and have instantly clear vision. As well, sleeping in
respiratory gases. lenses for an extended period obviated the need for routine
If a contact lens blocks off the normal oxygen supply, the daily lens cleaning and maintenance, which is necessary for all
corneal epithelium will become hypoxic and will begin to daily wear lenses with the exception of daily disposable lenses
respire anaerobically. This leads to a buildup of lactic acid, (see Section 6.633.7.2).
which diffuses into the corneal stroma, creating an osmotic Whereas oxygen reaches the cornea during open eye wear
force that draws in water. The cornea then develops edema and by diffusing from the atmosphere, through the lens to the
becomes less transparent, and the eye becomes uncomfortable. cornea, the closed eyelid blocks off this oxygen supply when
Carbon dioxide that is prevented by a contact lens from escap- the eyes are closed. The rich plexus of capillary vessels in the
ing from the corneal surface dissolves in the tears forming conjunctiva on the inside of the eyelid (the superior palpebral
carbonic acid (Figure 17). The resulting acidosis compromises conjunctiva) becomes the main source of oxygen for the cornea
the physiological integrity of the cornea to a small extent – but during sleep; however, the partial pressure of oxygen in the
the effects of hypoxia are far more critical.63 superior palpebral conjunctiva is about one-third of that in
The solution to the problem of hypoxia is to design contact the atmosphere.65 Therefore, the oxygen supply to the cornea is
lenses that maximize corneal oxygenation during lens wear, as markedly reduced during sleep.
explained in Section 6.633.2.5. Because soft contact lenses Many changes can be observed in the cornea in association
completely cover the cornea, the only option for preventing with chronic low level hypoxia and edema, as they occur
hypoxia is to use soft materials that are permeable to oxygen. during sleep. The most critical of these chronic changes is a
As explained in Section 6.633.2.5, the ease with which oxygen structural and metabolic weakening of the corneal epithelium.
can diffuse through a contact lens (defined by the term ‘oxygen An intact epithelium provides a vital defense against invasion
transmissibility’) is a function of the oxygen permeability of by potentially pathogenic microorganisms that could either
the hydrogel material from which the lens is made and the enter the eye by chance or in a lens wearer, via contaminated
thickness of the lens. A thinner lens provides less resistance to fingers and/or contact lens storage solutions. Opportunistic
oxygen flow; however, nothing much can be done about lens pathogenic microorganisms – such as pseudomonas aerugi-
thickness, because a lens must have a certain thickness profile nosa or acanthamoeba – can invade the epithelium and estab-
to achieve the desired optical power for vision correction. lish a potentially sight-threatening corneal infection.
Furthermore, if a lens is made too thin, it will fall apart. This Recent epidemiological studies have demonstrated that,
leaves material oxygen permeability as the only variable, and despite the introduction of highly oxygen permeable silicone
Corneal
endothelium
Sclera Corneal
stroma
Contact
lens Aqueous Corneal
humor epithelium
Ciliary body
4
Tear
Cornea Increased film
Oxygen
CO2 thickness
3
Wate
r Lactic
Crystalline
acid
lens Oxyg
2 en
Iris
1
Anterior chamber
containing aqueous
humor
Contact lens
(a) (b) blocks oxygen
Figure 17 (a) Cross-section of an eye wearing a contact lens, which impedes ingress of oxygen into, and the egress of carbon dioxide from, the
cornea. (b) The contact lens blocks oxygen supply to the cornea (1), causing lactic acid to accumulate in the stroma (2). This draws in water (3), leading
to stromal edema (4). Adapted from Efron, N. Biol. Sci. Rev. 1997, 9, 29–31.
hydrogel contact lenses, the incidence of severe corneal infec- such as parameter and/or design unavailability, and should be
tions (microbial keratitis) with extended wear silicone hydro- a comparatively rare event.
gel lenses is about five times greater than for daily hydrogel While the need to clean and disinfect multiuse soft lenses is
lens wear.66 Accordingly, overnight lens wear is discouraged by self-evident, a powerful argument for prolonging the life of
many eye care practitioners. Certainly, those who do sleep in lenses with elaborate lens care systems emerged in the early
lenses must be informed of the extra risks of adverse complica- days of soft lenses because of their relatively high cost of
tions. If a problem is encountered and treatment is delayed, the production. By the start of the 1980s, soft lenses were becom-
consequent infection can be extremely painful and lead to ing the preferred option in many countries. To achieve the then
some loss of sight (although true ‘blindness’ is extremely lens life norm of at least a year, a minimum of three lens care
rare). Most of the sensational reports that occasionally appear product types were needed. Daily cleaners were used to remove
in newspapers describing problems with contact lenses can be loose deposits and microorganisms from the lens surface; dis-
traced to patients sleeping in lenses. infecting solutions were used to kill any remaining microor-
Notwithstanding concerns about extended contact lens ganisms; and protein removal treatments were used to reduce
wear as outlined above, there is now an abundance of evi- the buildup of tear proteins on the lens surface. The ongoing
dence demonstrating the health benefits of silicone hydrogel cost of these products was often found to be more than that of
lenses for daily contact lens wear.42,67 This lens material has the contact lenses themselves.
essentially eliminated hypoxia-related contact lens complica- Planned replacement lenses (excluding daily disposable
tions, making daily contact lens wear a healthy vision correc- lenses) still need high standards of lens care to ensure safe
tion option. wear, but the shorter replacement cycles allow some scope for
Most of the problems encountered today relating to contact simplification. It should not be necessary to deproteinize
lens wear can be traced to patient noncompliance, whereby lenses changed at least monthly. In cases where lens surface
lens wearers fail to adhere to advice and guidelines offered by spoliation is a problem with monthly replacement, shortening
their practitioners or the lens manufacturers. Noncompliant the replacement interval to 2 weeks or even 1 day is likely to be
behaviors include improper lens maintenance, failing to a superior option – at least in terms of patient convenience and
replace lenses according to the prescribed replacement fre- therefore compliance – than adding a protein removal step to
quency, or sleeping in lenses designed for daily wear only. the care regime.
While mechanical daily cleaning, rinsing, and disinfection
are still essential in the care of 2-weekly and monthly replace-
6.633.7.2. Manufacturing Developments: Planned Lens
ment lenses, in most cases these functions can be effectively
Replacement
achieved with a single lens care product, namely a multipur-
‘Planned replacement’ refers to lens replacement at intervals from pose solution.77 Daily disposable lenses, which are discarded
1 day to 12 months and therefore, includes all ‘disposable lenses,’ each day following lens removal, by definition require no lens
which are defined as lenses replaced at least monthly. The first maintenance.
disposable lenses were released internationally in the mid-1980s. Because planned replacement lenses are supplied in multi-
The acceptance of disposability by practitioners and patients has packs, it follows that the loss or damage of a lens should not, in
been one of the most significant changes in the worldwide con- most cases, be an inconvenience to a patient. Practices fitting
tact lens market over the past two decades. By 2005, UK practi- disposable lenses are also likely to have numerous trial lenses,
tioners were fitting 99% of their new soft lens patients with and even stocks of the more popular parameters, on the
disposable lenses, compared with 61% 10 years before.68 premises, which enable rapid replacement if lens loss or
The rationale for the planned replacement of soft contact damage occurs.
lenses is simple: cleaner lenses should produce fewer adverse Planned replacement protocols require patients to return
ocular effects. A significant proportion of clinical problems at regular intervals for fresh lenses. Aftercare visits can be
relating to the wear of soft contact lenses can be attributed to scheduled to coincide with lens collection, which is a further
deposition on the lens surface with tear-derived substances. benefit of prescribing this modality. However, regular repurch-
Contact lens deposits result in reduced acuity, comfort, and asing does not necessarily imply compliance with the wearing
wettability and increased inflammatory complications such as schedule.78,79
papillary conjunctivitis and acute red eye.69 Prior to the introduction of disposable lenses, practitioners
All soft contact lenses suffer gradual spoliation from the maintained sets of ‘trial lenses’ which were used to assess the fit
environment and tear-film components over time. Daily clean- of a lens on a given patient, and then cleaned and reused on
ing and periodic protein removal can slow this rate of deposi- subsequent patients. In the case of disposable lenses, new
tion but not prevent its occurrence. By ensuring that soft lenses diagnostic or trial lenses are used with each patient, and dis-
are replaced at a suitable predetermined interval, one of the posed of thereafter. This eliminates the risk of cross-infection
most enduring medical management axioms – that of preven- from a previous wearer of the lens. It also has the advantages of
tion being better than cure – is brought to bear. In practice, eliminating the time-consuming chore of trial lens cleaning,
patients who replace lenses regularly report fewer symptoms disinfection, and storage.
and exhibit less physiological changes in most instances,70–75 With the ready availability of a comprehensive stock of trial
compared with patients who do not replace lenses regularly. lenses, it is nearly always possible to undertake a lens-wearing
Specific benefits arise from the use of planned replacement trial on a prospective disposable lens patient with the required
lenses;76 these are so compelling that any decision not to lens parameters, especially with respect to lens power. This was
prescribe soft lenses on this basis requires special justification, not the case prior to the introduction of disposable lenses,
when practitioners could only maintain a trial set with a lim- Hypoxia-related problems with conventional hydrogels
ited range of parameters. Trial fitting with a lens with para- were alleviated to some degree by reducing the thickness of
meters that closely match the requirement of the patient allows the lenses and/or utilizing more hydrophilic monomers. How-
for a realistic subjective impression of lens wear and assists the ever, these materials still fell far short of the oxygen require-
practitioner to accurately assess the fit of what is likely to be the ments needed for truly safe continuous wear.
final lens specification in many instances. For certain specialist Although the various hypoxia-related problems associated
fittings, such as presbyopia, trial fitting is more meaningful if with contact lens wear appear to have been resolved with the
the appropriate lens powers for the refractive condition of the new breed of silicone hydrogel materials, a number of mechan-
patient are used. ical and surface material-related complications still remain,
By the very nature of planned replacement, it is straightfor- despite the introduction of ‘second generation’ silicone hydro-
ward to modify the prescription of a patient, particularly with gel polymers. Future development of soft contact lens materials
respect to changes in refractive error. From a practice manage- is likely to concentrate on trying to resolve the issues of inflam-
ment viewpoint, it is advisable to carry out the annual aftercare mation and infection, improving lens comfort, enhancing
appointment prior to the dispensing of the next supply of postlens tear exchange, and improving surface wettability.
lenses for the patient. Any alteration in lens power can then The three primary methods of manufacturing soft contact
be made without the need to exchange unwanted lenses. lenses are lathe cutting, spin casting, and cast molding. The
There are probably no clinical disadvantages in prescrib- technique of cast molding has become the dominant form
ing planned, as opposed to unplanned, replacement lenses. of soft contact lens manufacture, because it is capable of pro-
However, there are some points to bear in mind that may ducing sufficient quantities of high-quality lenses so as to meet
have negative implications. The potential for practitioner the intense clinical demand for affordable planned replace-
and patient noncompliance with the designated replacement ment and disposable lens-wearing modalities. Modern soft
frequency is ever present.80 lens manufacturing techniques produce lenses of high quality
Provided lens fitting, aftercare, and patient education are of and good reproducibility.
a good standard, there are no compelling reasons for avoiding Planned contact lens replacement, especially in the form of
planned replacement, as long as the required parameters are disposable soft lenses, has transformed contact lens practice
available. over the past two decades. This approach is clearly justified in
With any lens replaced at least monthly, it is not practical terms of clinical performance, increased convenience, and
for each lens to be inspected in detail, either prior to insertion practice profitability. With the increasing popularity of daily
or in the eye of the patient. For planned replacement to be disposable lenses, it is likely that this lens type will be used
successful, it is a requirement that lenses are sufficiently con- with greater frequency, and it may not be long before all
sistent in quality such that the patient will not notice any contact lenses are supplied on this basis. Indeed, we predict
change in comfort, fit, or visual acuity from lens to lens. that by the year 2020, the vast majority of contact lenses will be
Certainly, the various types of molding systems used to pro- daily disposable products made of advanced silicone hydrogel
duce most disposable lenses are developed on the principle of materials.
building quality into the product, as the traditional manual
methods previously used by manufacturers to examine con-
ventional lenses would not be cost-effective with a mass- Appendix A. Classification of Soft Lens Materials
produced lens.
A.1. FDA Classification System
Wider quality issues are also important when the patient is
using many lenses each year. Consistency of packaging and The FDA classification system for soft lens materials is shown
labeling are of great significance when the patient is supplied in Table A.1. The classification system has four groups. The
with unopened packages. If patients find that some blister main drawback with this system is that different materials
packs are empty or dry, or contain more than one lens, their containing different monomers can be classified within the
confidence in the product is likely to be reduced. same material group.
Notwithstanding the above considerations, the recent liter-
ature is free of descriptions of complications attributable to
A.2. ACLM Classification System
poor disposable lens quality; nevertheless, patients should be
advised to inspect visually all lenses prior to insertion and The ACLM classification has two main groups: focon for rigid
discard any lenses exhibiting surface or edge defects, or lenses lens materials and filcon for soft lens materials. Each group is
that are persistently uncomfortable, cause significant eye red- further subdivided depending on how much ionizable
ness, or provide poor vision.
Table A.1 FDA classification system for soft lens materials

6.633.8. Conclusions
Group Material
Soft contact lenses have come a long way since the pioneering
efforts of Professor Otto Wichterle in the late 1950s in terms of I Low water content (<50%), nonionic polymers
II High water content (>50%), nonionic polymers
material, design, and the way they are manufactured. Thick
III Low water content (<50%), ionic polymers
pHEMA lenses which were replaced every few years are now a
IV High water content (>50%), ionic polymers
thing of the past.
Table A.2 FDA classification system for soft lens materials Table A.4 BS EN ISO hydrogel Dk groups
Group Material Group Dk range
1a Essentially poly 2-HEMA, but 0.2% by weight of any ionizable 0 <1 Dk unit
chemical (e.g., MA) 1 1–15 Dk units
1b Essentially poly 2-HEMA, but >0.2% by weight of any ionizable 2 16–30 Dk units
chemical 3 31–60 Dk units
2a A copolymer of 2-HEMA and/or other 4 61–100 Dk units
hydroxyalkylmethacrylates, dihydroxyalkylmethacrylates, 5 101–150 Dk units
and alkylmethacrylates, but 0.2% by weight of any 6 151–200 Dk units
ionizable chemical 7 etc. Increasing in increments of 50 Dk units
2b As in group 2a, but >0.2% by weight ionizable chemicals
3a A copolymer of 2-HEMAwith an N-vinyl lactam and/or an alkyl
acrylamide but 0.2% by weight of any ionizable chemical by mass (hydrogel materials). Focon is applied to materials
3b As in group 3a, but >0.2% by weight of ionizable chemicals
containing <10% water by mass (i.e., nonhydrogel materials).
4a A copolymer of alkyl methacrylate and N-vinyl lactam and/or an
The Series suffix is also administered by the USAN council,
alkyl acrylamide, but 0.2% by weight of any ionizable
chemical and is used in cases in which the original ratio of the mono-
4b As in group 4a but >0.2% by weight of ionizable chemical mers of an existing contact lens polymeric material is changed
5 Soft lens materials formed from polysiloxanes to make a new material. In this case, the capital letter ‘A’ is
added after the stem designation. Subsequent changes in
monomer ratio are designated by the next letter of the alpha-
bet. These letters are used to differentiate copolymers of
Table A.3 BS EN ISO hydrogel suffix groups unchanged monomer units, but with different ratios.
The Group suffix, represented by a Roman numeral, indicates
Group Material
the range of water content and ionic character of the material
suffix
(Table A.3).
I Low water content, nonionic: materials which contain less Table A.4 shows how the oxygen permeability of the materials
than 50% water and 1% or less (expressed as mole is classified.
fraction) of monomers that are ionic at pH 7.2 The Modification code, designated by a letter ‘m’ denotes
II Medium and high water content, nonionic: materials which whether the lens has a surface modification which renders the
contain 50% water or more and 1% or less (expressed as surface characteristics different from that of the bulk material.
mole fraction) of monomers that are ionic at pH 7.2 Such treatments include plasma treatment, acid/base hydroly-
III Low water content, ionic: materials which contain less than
sis, and incorporation of a material which migrates to the
50% water and greater than 1% (expressed as mole
surface. Certain types of tinted lenses may also be considered
fraction) of monomers that are ionic at pH 7.2
IV Medium and high water content, ionic: materials which surface modified. In the case of an unmodified surface, this
contain 50% water or more and greater than 1% suffix is omitted.
(expressed as mole fraction) of monomers that are ionic
at pH 7.2 A.3.1. Example
In order to demonstrate the BS EN ISO classification system,
the Acuvue 2 lens would be classified as follows:
monomer is present in the material. The classification system is Prefix – eta
shown in Table A.2. Stem – filcon
Series suffix – A
A.3. BS EN ISO 18369-1: 2006 Group suffix – IV
Dk range – 1
The specific classification of a contact lens or contact lens Modification code – none
material is given as a six-part code as follows:
(prefix) (stem) (series suffix) (group suffix) (Dk range) The lens can, therefore, be classified as (etafilcon A) (IV) (1).
(modification code)
For soft lens materials, the classification denotes whether
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6.633.

Development of Contact Lenses from a Biomaterial Point of

6.633.1. Introduction 519

Glossary Conjunctival staining Disruption of the superficial

Abbreviations FM0411M Methacryloyloxyethyl

NVP N-vinyl pyrrolidone SFrad Radial swell factor

6.633.1. Introduction accepted as being their lack of comfort and, in particular,

Swell factor ðSFÞ ¼ Wet dimension=dry dimension

CH3 higher water contents. Producing lenses which were thinner

Table 1 Conventional soft (hydrogel) lenses

Name Manufacturer/supplier Principal components W (%) USAN nomenclature

FDA Group I (<50% EWC <0.2% ionic content)

CH3 CH2 CH3 CH3 CH2 CH3

PDMS TRIS TPVC

Hydrated lens Anhydrous lens

6.633.6.2. Spin Casting

Hydrated lens Lens hydrated Anhydrous lens

Lens is inserted Blister pack containing Blister pack and lens

Figure 13 Manual inspection of contact lens quality. Reprinted with

Figure 11 Polypropylene molds being prepared for lens for casting.

Figure 12 Automated production line for cast-molding soft contact

Female mold Male mold

Female mold Female mold

Table A.1 FDA classification system for soft lens materials

Group Material Group Dk range

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