Mertens - The Staar Toric ICL

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COVER STORY

The STAAR
Toric ICL
This lens reduced preoperative spherical and astigmatic errors
with high predictability and good stability.
BY ERIK L. MERTENS, MD, FEBO

efractive surgery options to correct moderate

R to high myopia and myopic astigmatism are


limited. LASIK, PRK,1-2 LASEK, and more recent-
ly Epi-LASIK, have lower predictability and safe-
ty compared with the treatment of moderate myopia
with or without astigmatism.
Most refractive surgerons believe
that phakic IOLs will become the
implant of choice for certain forms of
refractive correction.
Complications reported for laser correction of high
refractive errors include corneal ectasia, low predictabili-
ty, poor quality of vision under dim illumination, and copolymer, collamer. From November 2003 to present,
regression.3-4 Refractive lens exchange permits correction 166 Toric ICLs have been implanted at the Antwerp Eye
of the refractive error, however, accommodation is often Center. The myopic correction ranged from -2.00 D to
lost in young patients and the risk of retinal detachment -14.00 D, and the cylindrical correction ranged from -1.00
is high.5 The implantation of IOLs in the eye has been D to -5.25 D.
part of cataract surgery practice for many years; it is only
in more recent years, however, that these implants are PATIENTS AND METHODS
available for refractive correction. Patients between the ages of 18 years and 50 years with
Most refractive surgeons believe that phakic IOLs will stable refraction for at least 1 year and astigmatism
become the implant of choice for certain forms of refrac- greater than 1.00 D, and who also had an otherwise nor-
tive correction. Over the last few years, phakic lenses for mal ophthalmologic examination, were included in our
correction of high ametropia have been implanted with study. Preoperative counseling (ie, outline of [1] potential
satisfactory results. The accuracy of refractive implants in intraocular surgery complications, [2] alternative refrac-
restoring vision is acknowledged6 and regarded highly, tive techniques, and [3] their respective benefits and
because the insertion procedure offers a method of cor- risks) took place at initial consultation. Exclusion criteria
rection that is removable, predictable, rapidly healing were anterior segment pathology; anterior chamber
and does not permanently alter the shape or structures depth from the endothelium fewer than 2.8 mm; abnor-
of the cornea. mal iris function; recurrent uveitis; any form of cataract,
The difficulties now lie in convincing the patient. glaucoma, retinal detachment, preexisting macular degen-
General patient consensus is that laser surgery is more eration or macular pathology; chronic treatment with
attractive, because IOL implantation is far too invasive. corticosteroids or any immunosuppressive treatment or
Another option, however, is to suggest a toric ICL. state; and pregnancy.

TORIC PHAKIC I OL SURGIC AL PRO CEDURE


The new Toric ICL (STAAR Surgical, Monrovia, Two Nd:YAG laser iridotomies at 10:30 o’clock and
California) is made of STAAR’s proprietary collagen 1:30 o’clock were performed at least 1 week before sur-

52 I CATARACT & REFRACTIVE SURGERY TODAY EUROPE I NOVEMBER/DECEMBER 2006


COVER STORY

gery. The horizontal axis was marked with a pointed


marker at the limbus immediately before surgery. At
the operation table, the left eye underwent surgery
first. Povidone iodine 10% (Iso-betadine; Viatris, Bad
Homburg, Germany) was applied to the eyelids; the
patient was draped, and a lid speculum was inserted.
Four drops of oxybuprocaine hydrochloride 4 mg/mL
(Unicaine; Bournonville Pharma, Breda, Netherlands)
was used to anaesthetise each eye. Three minutes
before corneal incision, povidone iodine 5% was
administered to the ocular surface. A paracentesis was
placed superiorly for the left eye and inferiorly for the
right eye, and methylcellulose 20 mg/mL (Ocucoat;
Bausch & Lomb, Rochester, New York) was injected
into the anterior chamber.
A 2.65-mm temporal clear corneal incision was made Figure 1. The Toric ICL was rotated according to implantation
with a 30° stab knife and a 2.65 mm blade (Bausch & software.

TCL IMPLANTATION: A STRAIGHTFORWARD TECHNIQUE

In the case of treating myopic patients with astigma- treatment may form a useful combination with TCL
tism, the Toric ICL (TCL; STAAR Surgical, Monrovia, implantation to correct lower-order abberations. Many
California) can provide beneficial results, said Bruce Allan, post keratoplasty patients require relatively high myopic
MD, from the Moorfield Eye Hospital, London, in a tele- and astigmatic corrections, which may be associated
phone interview with Cataract and Refractive Surgery with a greater degree of haze and postoperative regres-
Today Europe. sion where the laser alone is used. Using the TCL to pro-
Dr. Allan began using the TCL earlier this year and vide the bulk correction brings any laser correction
described the implantation technique as “very straight- down to the fine tuning level, and dual approach (ie, a
forward.” The wound construction is identical to the variation of bioptics) may have a lot of mileage in the
standard ICL implantation technique, but unlike stan- future of postkeratoplasty refractive correction. TCL
dard ICLs, the patient is marked preoperatively to control implantation alone produces considerable benefit for
for cyclotortional changes after the patient is lying down. most patients in this group.
During this part of the procedure, the 0º and 180º points According to Dr. Allan, postoperative lens rotation can be
are marked at the slit lamp. The patient is then taken to a downside to this procedure, but it is relatively infrequent
operating theater, and with the degree maker, the sur- compared with rotational problems experienced with in the
geon marks the requisite point—identified on the bag toric IOLs used postcataract surgery, and easier to cor-
implantation diagram that STAAR Surgical has provided rect. He said the consensus view on correction is that it is
based on subjective refraction along with keratometry worth trying a simple rotation once, and exchanging the
information from corneal topography. Having marked TCL for a size larger if an axis misalignment recurs.
the orientation of the TCL, a surgeon can align the lens Dr. Allan says his own experience and results already
as they position the footplates, meaning they do not presented for the TCL are very encouraging. “Given the
have too much rotation to complete once the lens is sul- choice between implanting a TCL or using a myopic ICL
cus placed, Dr. Allan said. plus an incisional technique to correct astigmatism, I
Completeness of astigmatic correction using the TCL think there is no contest; the toric ICL is more reliable in
depends on whether you are looking at postkeratoplasty terms of the visual result.” ■
keratoconus patients who may have a component of
irregular astigmatism or a straightforward case of con- Bruce Allan, MD practices at the Moorefield’s Eye
genital astigmatism. Congenital astigmatism is predomi- Hospital & Institute of Ophthalmology, in London. Dr. Allan
nantly regular, whereas postkeratoplasy astigmatism may states that he has no financial interest in the products or
have a significant irregular component. In the future, companies mentioned. He may be reached at
fine-tuning with topography-guided preliminary laser [email protected].

NOVEMBER/DECEMBER 2006 I CATARACT & REFRACTIVE SURGERY TODAY EUROPE I 53


COVER STORY

Figure 2. Eyes within 0.50 D of intended refraction. Figure 4. The efficacy index at 3 months.

Riyadh, Saudi Arabia); lomefloxacin 3 mg/mL (Okacin


collyre; Ciba Vision, Duluth, Georgia); and a terracortril
suspension (hydrocortisonacetaat 17 mg, oxytetracy-
cline 5.7 mg, polymyxine B 11400 IE/g; Pfizer, New York,
New York) were then instilled. Immediately after sur-
gery, acetazolamide 250 mg (Diamox, Haupt Pharma,
Berlin) was administered to minimize IOP. It was then
readministered 1 day postoperatively.
In all cases, bilateral surgery was undertaken. The sur-
geon’s gown and gloves were changed, and a separate set
of surgical instruments was used. Povidone-iodine solu-
tion was instilled before surgery for a second time. A dif-
ferent lot of BSS, methylcellulose and vancomycin was
used in all cases.
The patient’s postoperative medication included
infectoflam collyre (fluorometholone 1 mg/mL, gen-
Figure 3. Eyes within 1.00 D of intended cylindrical correction. tamycin 3 mg/mL; Novartis, Basel, Switzerland) and indo-
collyre (indomethacin 1 mg/mL; Chauvin
Lomb). Methylcellulose 20 mg/mL was then readminis- Pharmaceuticals, Surrey, UK) administered four times
tered into the anterior chamber. daily for the first week, tapering to one daily drop 4
Under the microscope, the Toric ICL was loaded into weeks postoperatively. Additionally, hyabak collyre (sodi-
the STAAR injector cartridge using Vukich ICL forceps um hyaluronate 1.5 mg/mL; Thea) and genteal gel
(ASICO, Westmont, Illinois) and modified Aus der Au (hypromellose 3 mg/mL; Ciba Vision) were administered
forceps (Janach, Como, Italy). The tip of the injector four times daily for 1 month. Postoperative examinations
cartridge was then inserted into the temporal corneal were at 1 day, 1 week, 1 month, and 3 months.
wound, the Toric ICL was delivered, and the haptics
were placed behind the iris with a manipulation for- RE SULTS
ceps (Duckworth & Kent, Baldock, Hertfordshire, Predictability. Three months after surgery, 94% of
England). The Toric ICL was rotated according to the eyes (n=63) were within ±0.50 D of the intended refrac-
implantation software (ie, clockwise or counter-clock- tion, and 100% were within ±1.00 D (Figure 2).
wise) (Figure 1). Predictability: Astigmatic correction. A total of
The methylcellulose was irrigated out with copious 94.5% eyes (n=87 of 92) were within 1.00 D of intended
Balanced Salt Solution (BSS; Alcon Laboratories, Fort cylindrical correction (Figure 3). Three ICLs were mis-
Worth, Texas), and vancomycin 6 mg/mL was instilled aligned and needed to be rotated into the correct axis; all
into the anterior chamber. One drop of dorzolamide 20 occurred without any problem.
mg, timolol 5 mg/mL suspension (Cosopt; MSD, Efficacy. Three months after surgery, the overall effi-

54 I CATARACT & REFRACTIVE SURGERY TODAY EUROPE I NOVEMBER/DECEMBER 2006


COVER STORY

cacy index (ie, mean postoperative UCVA/mean pre-


operative BSCVA) was 112.2%. In 94% of eyes, postop-
erative UCVA was 20/25 or better; in 87% of eyes
20/20 or better; and in 30% of eyes 20/16 or better
(Figure 4). All improvements in UCVA and BSCVA
were statistically significant.
Complications. Three percent of eyes (n=5) required a
secondary intervention. In two eyes, acute angle closure
glaucoma occurred—due to excessive vault of the Toric
ICL—where the lens needed to be explanted. This sizing
issue, however, did not occur again, since we used the
Vumax II (Sonomed, Lake Success, New York). This ocular
high frequency ultrasound biomicroscopy (UBM) device
accurately measures the sulcus-to-sulcus diameter. In our
most recent 86 ICL implants, 16 eyes had a discrepancy in
sulcus-to-sulcus diameter with respect to the white-to-white
corneal diameter. By readjusting the ICL size to the sulcus-to-
sulcus diameter, no more excessive vaulting occurred post-
operatively. Three Toric ICLs were misaligned and needed to
be rotated into the correct axis. The repositioning of these
lenses was performed after approximately 1 month, because
of a 15° to 25° deviation from the target axis. No potentially
sight-threatening complications (eg, iris prolapse, iris atrophy, Figure 5. Some eyes received an ICL that was larger than
touch of the anterior capsule, persistent corneal edema, suggested by white-to-white measurements.
cataract formation, retinal detachment, endophthalmitis,
serofibrinous reaction) were reported during follow-up. ametropia has advantages over corneal procedures (eg,
predictabiltiy and stabiltiy of the refractive outcome).
CONCLUSI ON Interest in these lenses for the correction of refractive
With the introduction of the Toric ICL, the need for com- errors has increased.
bining posterior chamber phakic IOL implantation with ker- Data has shown that the Toric ICL reduced preoperative
atorefractive procedures (ie, bioptics) is significantly spherical and astigmatic errors with high predictability and
reduced, avoiding possible complications or problems (eg, good stability and was associated with extremely good visu-
flap striae, reduction in contrast sensitivity under low-light al outcomes and strong patient satisfaction. Complications
conditions, haze) of any additional keratorefractive proce- were minimal and amenable to treatment. ■
dure. Both spherical and cylindrical correction are com-
bined in the Toric ICL, which aims to correct the total Erik L. Mertens, MD, FEBO, is the medical
corneal astigmatism and lens astigmatism refractive error.7 director of the Antwerp Eye Center, in Antwerp,
Three months after surgery, all eyes were within ±1.00 D of Belgium. Dr. Mertens states that he is a paid
the predicted correction; 94% were within ±0.50 D. The consultant for Bausch & Lomb and STAAR
UCVA was 20/40 or better in 98% of eyes and 20/20 or bet- Surgical. He may be reached at [email protected];
ter in 87% of eyes. This level of efficacy is hard to achieve telephone +32 3 8282949; or fax +32 3 8208891. Dr. Mertens
with other phakic IOLs or laser refractive procedures. is a member of the CRST Europe Editorial Board.
With the introduction of new generation UBM instru-
1. Buratto L, Ferrari M, Genisi CM, Genisi C. Myopic keratomileusis with the excimer laser:
ments such as the Vumax II, accuracy in sizing the Toric one year follow up. Refract Corneal Surg. 1993;9:12-19.
ICL has improved dramatically. In 18.6 % of eyes, another 2. Sher NA, Barak M, Daya S, et al. Excimer laser photorefractive keratectomy in high myopia.
A multicenter study. Arch Ophthalmol. 1992;110:935-943.
ICL size other than that suggested by the corneal white-to- 3. Seiler T, Holschbach A, Derse M, et al. Complications of myopic photorefractive keratec-
white measurements needed to be implanted. By doing tomy with the excimer laser. Ophthalmology. 1994;101:153-160.
4. Seiler T, Koufala K, Richter G. Iatrogenic keratectasia after laser in situ keratomileusis. J
this, sizing became a nonissue in my practice (Figure 5). Refract Surg. 1998;14:312-317.
Removability is an important consideration for both 5. Lee KH, Lee JH. Long-term results of clear lens extraction for severe myopia. J Cataract
Refract Surg. 1996;22:1411-1415.
the surgeon and the patient, especially in comparison 6. Bartels MC, Santana NTY, Budo C, et al. Toric phakic intraocular lens for the correction of
hyperopia and astigmatism. J Cataract Refract Surg. 2006;32:243-249.
with other refractive corneal surgical procedures that 7. Mertens E. Integrating phakic IOLs in a private practice. Ophthalmology Times.
permanently alter the cornea. The use of the Toric ICL in 2006;2:1:28-29.

NOVEMBER/DECEMBER 2006 I CATARACT & REFRACTIVE SURGERY TODAY EUROPE I 55

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