ARTICLE

Clinical study using a new

phacoemulsification system with surgical
intraocular pressure control
Kerry D. Solomon, MD, Ram

on Lorente, MD, Doug Fanney, MBA, Robert J. Cionni, MD

PURPOSE: To compare cumulative dissipated energy (CDE), aspiration fluid used, and aspiration
time during phacoemulsification cataract extraction using 2 surgical configurations.
SETTING: Two clinical sites in the United States and 1 in Spain.
DESIGN: Prospective randomized clinical case series.
METHODS: For each patient, the first eye having surgery was randomized to the active-fluidics
configuration (Centurion Vision System with Active Fluidics, 0.9 mm 45-degree Intrepid
Balanced tip, and 0.9 mm Intrepid Ultra infusion sleeve) or the gravity-fluidics configuration
(Infiniti Vision System with gravity fluidics, 0.9 mm 45-degree Mini-Flared Kelman tip, and
0.9 mm Ultra infusion sleeve). Second-eye surgery was completed within 14 days after first-eye
surgery using the alternate configuration. The CDE, aspiration fluid used, and aspiration time
were compared between configurations, and adverse events were summarized.
RESULTS: Patient demographics and cataract characteristics were similar between configurations
(100 per group). The CDE was significantly lower with the active-fluidics configuration than with the
gravity-fluidics configuration (mean G standard error, 4.32 G 0.28 percent-seconds) (P < .001).
The active-fluidics configuration used significantly less aspiration fluid than the gravity-fluidics
configuration (mean 46.56 G 1.39 mL versus 52.68 G 1.40 mL) (P < .001) and required
significantly shorter aspiration time (mean 151.9 G 4.1 seconds versus 167.6 G 4.1 seconds)
(P < .001). No serious ocular adverse events related to the study devices or device deficiencies
were observed.
CONCLUSION: Significantly less CDE, aspiration fluid used, and aspiration time were observed with
the active-fluidics configuration than with the gravity-fluidics configuration, showing improved
surgical efficiency.
Financial Disclosures: Drs. Solomon and Cionni are consultants to Alcon Research, Ltd., and
received compensation for conduct of the study. Dr. Lorente received compensation for clinical
work in the study. Mr. Fanney is an employee of Alcon Research, Ltd.
J Cataract Refract Surg 2016; 42:542549 Q 2016 ASCRS and ESCRS

An estimated 20 million cataract surgical procedures intraocular pressure (IOP), which can vary during sur-
are performed annually, with phacoemulsification gery because of 2 primary factors. First, changes in
being the surgical method of choice.1,2 Advances in aspiration and infusion flow rates can cause fluctua-
phacoemulsifier/aspirator (phaco) systems, fluidics, tions in IOP. In addition, postocclusion break
ultrasound (US) tips, and US sleeves continue to be response, which occurs when fluid floods the aspira-
made with the goal of improving surgical efficiency tion port after a phacoemulsification tip is unoccluded,
and patient outcomes after cataract surgery. can create a transient pressure drop. The transient
Maintaining anterior chamber stability is a key decrease in surgical IOP during postocclusion surge
factor in facilitation of successful cataract surgery. events increases the risk for surgical complications
However, anterior chamber stability is affected by such as posterior capsule rupture.3,4 One of the newest

542 Q 2016 ASCRS and ESCRS http://dx.doi.org/10.1016/j.jcrs.2016.01.037

Published by Elsevier Inc. 0886-3350
 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS 543

phaco systems available is the Centurion Vision Sys- the phacoemulsification tip was in the eye) and was
tem (Alcon Laboratories, Inc.). This system can use associated with less postoperative corneal edema.10
standard gravity fluidics with an irrigation bottle or The new Centurion Vision System system improves
an Active Fluidics system with a compressible irriga- on the fluidics of the Infiniti Vision System, and
tion bag. When using the irrigation bag, the active together with the newly offered Intrepid Balanced
control system applies variable infusion pressure to US tip, might lead to better surgical efficiency during
compensate for variations in fluid flow rate and pro- cataract procedures. The goal of this study was to
vide for better surgical IOP stability by reducing IOP compare the intraoperative surgical efficiency metrics
fluctuations during surgery.A,B The postocclusion (cumulative dissipated energy [CDE], aspiration time,
response is also improved, as was recently shown in and aspiration fluid used) between the Centurion
a laboratory study comparing postocclusion surge be- system configured with the Intrepid Balanced tip
tween 3 currently used systems.5 The tested systems compared with the Infiniti system configured with
included the Infiniti Vision System (Alcon Labora- the standard Mini-Flared Kelman tip during routine
tories, Inc.) and the Centurion. The Centurion consis- phacoemulsification extraction of cataracts with lens
tently achieved the lowest postocclusion surge levels, opacities of nuclear (N) N0 to NIII, as classified by
suggesting the potential for better IOP stability during the Lens Opacities Classification System II (LOCS II).11
surgery.
The Infiniti was selected as a comparator in this PATIENTS AND METHODS
study because it is a commonly used phaco system.
Study Design
In a survey-based study of surgeons in Canada and
the United States, 59% reported that Infiniti was their This was a prospective randomized multicenter patient-
and clinical technician-masked 2-arm paired-eye compari-
first-choice system.6 son study performed at 2 sites in the United States and
The torsional US feature of the Infiniti system was 1 site in Spain between July 2013 and February 2014 (U.S. Na-
introduced in addition to traditional (ie, longitudinal) tional Institutes of Health Clinical Trials identifier
US; the torsional operating modality of the Infiniti NCT01848288).C Enrolled patients were randomized to 1 of
was shown to decrease heat production,7,8 surgical 2 surgical configurations for first-eye surgery in a ratio of
1:1 for each surgeon. Surgeons graded cataracts before
time, and aspiration fluid volume compared with tradi- randomization in an unmasked fashion by comparison
tional US.9,10 Compared with a phaco system operated with standardized LOCS II photographs.11 The eye with
in longitudinal mode, phacoemulsification with the In- the worse cataract was selected as the first operative eye. If
finiti system in torsional mode was completed with less the cataract grade was equal between eyes, the right eye
mean phacoemulsification time (ie, the duration that was selected. Second-eye surgery was performed within
14 days after first-eye surgery using the alternate configura-
tion. The active-fluidics configuration comprised the Centu-
rion Vision System with Active Fluidics, the 0.9 mm
45-degree aspiration bypass system Intrepid Balanced
Submitted: August 11, 2015. tip, and the 0.9 mm Intrepid Ultra infusion sleeve (Figure 1,
Final revision submitted: January 15, 2016. A). The gravity-fluidics configuration used the Infiniti Vision
Accepted: January 20, 2016. System with gravity fluidics, the 0.9 mm 45-degree aspira-
tion bypass system Mini-Flared Kelman tip, and the
From the Carolina Eyecare Physicians (Solomon), Charleston, 0.9 mm Ultra infusion sleeve (Figure 1, B). The Ozil hand-
South Carolina, Alcon Research, Ltd. (Fanney), Irvine, California, piece (Alcon Laboratories, Inc.) was used with both surgical
and the Eye Institute of Utah (Cionni), Salt Lake City, Utah, USA; configurations for all surgeries. Because all participating sur-
Complejo Hospitalario Universitario Orense (Lorente), Orense, geons had ample experience with the Infiniti system,
Spain. whereas the Centurion system was new, all investigators
were required to have used the Centurion 100 or more times
Supported by Alcon Laboratories, Inc., Fort Worth, Texas, USA. to gain sufficient experience before study initiation.
Bickol Mukesh, PhD, assisted with the statistical analyses. Medical
writing assistance was provided by Heather D. Starkey, PhD, Com- Patients
plete Healthcare Communications, Chadds Ford, Pennsylvania, Eligible patients provided written informed consent, were
USA, and was funded by Alcon Laboratories, Inc. 55 years or older with a diagnosis of cataracts with lens opac-
ities of N0 to NIII classified using the LOCS II,11 and had
Presented in part at the ASCRS Symposium on Cataract, IOL and planned bilateral phacoemulsification cataract extraction
Refractive Surgery, Boston, Massachusetts, USA, April 2014, and with implantation of Acrysof intraocular lenses (IOLs) (Al-
at the XXXII Congress of the European Society of Cataract and con Laboratories, Inc.). Patients must have been willing to
Refractive Surgeons, London, United Kingdom, September 2014. have second-eye surgery within 14 days of first-eye surgery.
Key exclusion criteria included nuclear opalescence cataract
Corresponding author: Kerry D. Solomon, MD, 1101 Clarity Road, LOCS II grading of NIV,11 planned multiple procedures at
Suite 100, Mount Pleasant, South Carolina 29464, USA. E-mail: the time of surgery, previous intraocular or corneal surgery
[email protected]. (eg, refractive or therapeutic), a poorly dilating pupil or

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544 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS

configuration specified during randomization for first-eye

and second-eye surgeries. Use of a femtosecond laser or
manual prechop technique was prohibited. After aspiration
of lens material, the appropriate IOL was implanted and
the procedure was completed per standard practice.

Outcome Measures
The primary efficiency outcomes were CDE and aspira-
tion fluid used. The secondary efficiency outcome was aspi-
ration time. Estimated fluid use, which was calculated by
each phaco machine, was evaluated as a supportive effi-
ciency outcome. The CDE was calculated using the same for-
mula for the active-fluidics system and the gravity-fluidics
system (CDE Z average energy amplitude  duty
cycle  time in foot position 3 [ie, active US time]). The aspi-
ration fluid was a balanced salt solution and was measured
by weighing the drainage bag to the nearest tenth of a gram
(ie, weight of fluid used Z weight before surgery weight
after surgery; 1 mL balanced salt solution Z 1 g balanced
salt solution). The CDE, aspiration time, and estimated aspi-
ration fluid used were recorded from the display on each
phaco system's user interface. Safety outcomes included
adverse events and device deficiencies that might have
occurred during the 3-month follow-up period.

Statistical Analysis
A sample size of 90 patients with complete data for both
eyes per surgical configuration was determined to be suffi-
cient to detect a between-configuration CDE difference of
more than 15% with 80% power at a 2-sided a of 0.05,
assuming a standard deviation (SD) of 50% of the mean
and a treatment effect of 0.3. A sample size of 90 patients
per configuration was also determined to be sufficient to
detect a difference in aspiration fluid used of at least 15%
Figure 1. Active-fluidics (A) and gravity-fluidics (B) surgical config- with 80% power at a 2-sided a of 0.05.
urations. Phacoemulsifier/aspirator systems, US tips, and infusion All patients who were randomized to a surgical configura-
sleeves are shown (ABS Z aspiration bypass system). tion for first-eye surgery comprised the intent-to-treat data-
set. All patients who received surgery were included in the
safety-analysis dataset. Data were summarized descriptively
pupil defect that prevented dilation to 5.0 mm or more or a for patient demographics and preoperative characteristics,
need for mechanical or surgical manipulation to enlarge efficiency outcomes, and safety outcomes. A random-effect
the pupil at the time of surgery, current or previous use of analysis of covariance model was used to test the treatment
an a1-selective or an a1A-selective adrenoceptor antagonist, differences in the primary and secondary efficiency out-
diagnosis of severe retinal disorders or history of retinal comes between the active-fluidics configuration and
detachment, clinically significant corneal endothelial dystro- gravity-fluidics configuration; this analysis was based on
phy, history of corneal disease, IOP greater than 21 mm Hg, the intent-to-treat dataset. Investigator site was included as
weak or broken zonular fibers, known zonular instability, or a covariate in the model. Analysis of the primary outcomes
zonular dehiscence. used a fixed sequence procedure, wherein statistical compar-
ison of aspiration fluid used was performed only if the com-
parison of CDE returned a statistically significant difference
Surgical Technique between configurations. Analysis of the supportive outcome,
Surgery was performed according to site-specific stan- aspiration time, was performed only if both primary out-
dard operating procedures: combination of divide-and- comes were significant. Two-sided P values less than 0.05
conquer plus stop-and-chop (K.D.S.), vertical chop (R.L.), were considered statistically significant.
and 4-quadrant divide-and-conquer (R.J.C.). Clear corneal
incisions of 2.2 to 2.4 mm and manually created capsulo- RESULTS
rhexes of 5.0 to 5.5 mm were used for all surgeries. Use of
the same ophthalmic viscosurgical device(s) (OVD) for a pa- Patients
tient's left eye and right eye was required: Duovisc (sodium One hundred patients were randomized to the first-
hyaluronate 3%chondroitin sulfate 4.0% with sodium eye surgery configuration (n Z 100 eyes per configura-
hyaluronate 1.0%) OVD system (K.D.S., R.J.C.) and Viscoat
(sodium hyaluronate 3.0%chondroitin sulfate 4.0%)Pro- tion; first-eye and second-eye surgeries combined) and
visc (sodium hyaluronate 1.0%) combination (R.L.). were included in the intent-to-treat dataset. Of these,
Phacoemulsification was performed using the surgical 98 patients had surgery and were included in the

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 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS 545

safety dataset. Three patients discontinued because of

Table 1. Baseline characteristics (intent-to-treat population).*
death (myocardial infarction unrelated to study treat-
ment), protocol violation (violation of exclusion crite- Number
rion, clinically significant corneal endothelial
Active-Fluidics Gravity-Fluidics
dystrophy), and withdrawal of consent (1 for each). Configuration Configuration
The mean patient age was 73.0 years G 7.7 (SD) (range Characteristic (n Z 100 Eyes) (n Z 100 Eyes)
56 to 90 years). Most patients were female (n Z 67) and
white (n Z 96). Nonwhite patients were 2 black/Afri- Nuclear color
NC0 7 8
can American, 1 Asian, and 1 American Indian/Alas-
NCI 53 54
ka Native. Preoperative patient characteristics in the
NCII 40 38
intent-to-treat population were similar between first- Nuclear opacity
eye surgical configuration groups (Table 1). The most N0 4 4
common cataract classifications in both groups were NI 29 32
nuclear color NCI, nuclear opacity NII, cortical opacity NII 50 45
CII, and posterior subcapsular opacity P0 (Table 1). NIII 17 19
Cortical opacity
Outcomes C0 19 17
C0Tr 2 2
A significantly lower CDE was observed with CI 27 27
the active-fluidics configuration than with the CII 39 38
gravity-fluidics configuration (least squares mean G CIII 13 16
standard error 4.32 G 0.28 percent-seconds versus Posterior subcapsular
7.11 G 0.28 percent-seconds) (Figure 2). The least opacity
squares estimate for the difference in means was P0 66 67
2.78 percent-seconds (95% confidence interval [CI], PI 19 19
3.44 to 2.13). The active-fluidics configuration PII 10 7
PIII 5 5
used significantly less aspiration fluid (measured
PIV 0 2
by weight) than the gravity-fluidics configuration;
*Cataract characteristics at baseline were graded using the Lens Opacities
Classification System version II.11

the least squares mean G standard error was

46.56 G 1.39 mL with the active-fluidics configuration
(Figure 3, A) and 52.68 G 1.40 mL with the gravity-
fluidics configuration (Figure 3, B). The least squares
estimate for the difference in the mean aspiration fluid
used was 6.12 mL (95% CI, 9.82 to 2.43). Aspira-
tion time was significantly shorter with the active-
fluidics configuration than with the gravity-fluidics
configuration (Figure 4). The least squares mean G
standard error aspiration time was 151.9 G 4.1 sec-
onds with the active-fluidics configuration and
167.6 G 4.1 seconds with the gravity-fluidics configu-
ration; the least squares estimate of the difference in
aspiration time between systems was 15.8 seconds
(95% CI, 26.5 to 5.1).
The aspiration fluid use estimates calculated
by each phaco machine generally agreed with the
measured fluid, as seen in the Bland-Altman plot
(Figure 5). On average, both configurations estimated
greater fluid use than measured fluid use. The mean
G SD magnitude of the systematic difference was
Figure 2. Cumulative dissipated energy. Data are presented as least
squares mean G standard error. The least squares estimate of the dif- numerically larger in the active-fluidics configuration
ference between group means is shown above bars. The P value was ( 4.3 G 5.6 mL) than in the gravity-fluidics configu-
determined using an analysis of covariance model. ration ( 2.7 G 8.8 mL).

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546 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS

Figure 4. Aspiration time. Data are presented as least squares mean

G standard error. The least squares estimate of the difference be-
tween group means is shown above bars. The P value was deter-
mined using an analysis of covariance model.

these events were not related to cataract removal treat-

ment. Treatment-emergent adverse events were re-
ported for 17 patients with the active-fluidics
configuration (20 events) and 18 patients with the
gravity-fluidics configuration (21 events). All ocular
adverse events observed during the study were unre-
lated to the study devices (Table 2). The most
frequently reported ocular adverse event was vitreous
detachment. Two problems during surgery were re-
ported with the active-fluidics configuration (1 IOL
haptic break and 1 zonular instability); these were
not related to the surgical configuration.

DISCUSSION
Cataract surgery, in particular small-incision phaco-
emulsification/aspiration cataract extraction, is gener-
Figure 3. Aspiration fluid used. A: Fluid used measured by weight ally a safe procedure.12 Advances in technology and
(least squares mean G standard error). The least squares estimate surgical techniques have shortened surgical times,
of the difference between group means is shown above bars. The reduced the risk, and improved outcomes.10,1316 Like-
P value was determined using an analysis of covariance model. B: wise, phaco systems that facilitate improved surgical
Fluid used as estimated by each phacoemulsifier/aspirator system
efficiency with reduced active instrumentation times,
compared with fluid used as measured by weight (mean G SD).
energy dissipated at the incision site, and fluid circula-
tion through the anterior chamber might further
No serious ocular adverse events or device defi- reduce the risk for potential surgical complications.
ciencies occurred. Two serious adverse events were re- In this contralateral-eye study, the CDE, aspiration
ported (1 fatal myocardial infarction and 1 infective fluid used, and aspiration time were significantly lower
exacerbation of chronic obstructive airway disease); for phacoemulsification cataract surgery with the

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 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS 547

Table 2. Ocular adverse events (safety population).

Patients, n (%)

Active-Fluidics Gravity-Fluidics
Configuration Configuration
Event (n Z 98 Eyes) (n Z 98 Eyes)*

Any ocular adverse 17 (17.3) 18 (18.4)

event
Vitreous detachment 6 (6.1) 6 (6.1)
Dry eye 2 (2.0) 3 (3.1)
Punctate keratitis 0 2 (2.0)
Allergic conjunctivitis 1 (1.0) 1 (1.0)
Eye disorder 1 (1.0) 1 (1.0)
Eye irritation 1 (1.0) 1 (1.0)
Meibomian gland 1 (1.0) 1 (1.0)
dysfunction
Ocular hyperemia 1 (1.0) 1 (1.0)
Vitreous floaters 1 (1.0) 1 (1.0)
Increased lacrimation 1 (1.0) 0
Reduced visual acuity 1 (1.0) 0
Foreign-body sensation 0 1 (1.0)
Retinal hemorrhage 0 1 (1.0)

*One patient randomized to first-eye surgery with the active-fluidics

configuration died from causes unrelated to the study before the sched-
uled second-eye surgery with the gravity-fluidics configuration.

The occurrence of adverse events with both configu-

rations was low, and no serious ocular adverse events
were reported. Furthermore, no device deficiencies
Figure 5. Difference between estimated and measured aspiration were observed with either configuration. The most
fluid use with the active-fluidics (A) and gravity-fluidics (B) surgical common adverse events were vitreous detachment
configurations. Estimated fluid use was recorded from each phacoe- (6%) and dry eye (2% to 3%); the frequency of these
mulsifier/aspirator machine's front display; measured fluid use was adverse events was comparable between configura-
determined by weight (1 g Z 1 mL).
tions. The adverse events in this study were similar
to the known safety profile of phacoemulsification
cataract extraction.1719
active-fluidics configuration (Centurion Vision System) A limitation of this study was that the phacoemulsi-
compared with the gravity-fluidics configuration (In- fication tips and sleeves differed between the active-
finiti Vision System). With the active-fluidics configura- fluidics and gravity-fluidics configurations. These
tion, the aspiration fluid used and aspiration time were variables might have contributed to the observed dif-
decreased by approximately 10% compared with the ferences in surgical efficiency between the Centurion
gravity-fluidics configuration and the CDE was Vision System and Infiniti Vision System phaco sys-
decreased by nearly 40%. Aspiration fluid used, as esti- tems, and the extent of the effect of the phaco tips on
mated by each phaco system, generally agreed with the efficiency parameters quantified is not known.
measured fluid used, although both systems overesti- These configurations were assessed because they rep-
mated fluid use to a small degree. resented the most commonly used configurations for
In the current study, the active-fluidics configura- the 2 systems; nevertheless, further evaluation using
tion and the gravity-fluidics configuration both used the same tip and sleeve for each phaco system would
the Ozil torsional handpiece and clear corneal inci- enable more direct assessment of efficiency differences
sions of 2.2 to 2.4 mm; however, the CDE was signifi- between the 2 systems. Furthermore, because the
cantly lower with the active-fluidics configuration Centurion Vision System was newly introduced at
than with the gravity-fluidics configuration. Together, the time of the study, recommended settings for the
these findings suggest that the active-fluidics configu- overall community of ophthalmic surgeons had not
ration achieved greater surgical efficiency than the yet been optimized. Although performing 100 previ-
gravity-fluidics configuration. ous surgeries provided surgeons with adequate

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548 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS

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