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
are performed annually, with phacoemulsification
being the surgical method of choice.1,2 Advances in
phacoemulsifier/aspirator (phaco) systems, fluidics,
ultrasound (US) tips, and US sleeves continue to be
made with the goal of improving surgical efficiency
and patient outcomes after cataract surgery.
Maintaining anterior chamber stability is a key
factor in facilitation of successful cataract surgery.
However, anterior chamber stability is affected by
intraocular pressure (IOP), which can vary during sur-
gery because of 2 primary factors. First, changes in
aspiration and infusion flow rates can cause fluctua-
tions in IOP. In addition, postocclusion break
response, which occurs when fluid floods the aspira-
tion port after a phacoemulsification tip is unoccluded,
can create a transient pressure drop. The transient
decrease in surgical IOP during postocclusion surge
events increases the risk for surgical complications
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
phaco systems available is the Centurion Vision Sys-
tem (Alcon Laboratories, Inc.). This system can use
standard gravity fluidics with an irrigation bottle or
an Active Fluidics system with a compressible irriga-
tion bag. When using the irrigation bag, the active
control system applies variable infusion pressure to
compensate for variations in fluid flow rate and pro-
vide for better surgical IOP stability by reducing IOP
fluctuations during surgery.A,B The postocclusion
response is also improved, as was recently shown in
a laboratory study comparing postocclusion surge be-
tween 3 currently used systems.5 The tested systems
included the Infiniti Vision System (Alcon Labora-
tories, Inc.) and the Centurion. The Centurion consis-
tently achieved the lowest postocclusion surge levels,
suggesting the potential for better IOP stability during
surgery.
The Infiniti was selected as a comparator in this
study because it is a commonly used phaco system.
In a survey-based study of surgeons in Canada and
the United States, 59% reported that Infiniti was their
first-choice system.6
The torsional US feature of the Infiniti system was
introduced in addition to traditional (ie, longitudinal)
US; the torsional operating modality of the Infiniti
was shown to decrease heat production,7,8 surgical
time, and aspiration fluid volume compared with tradi-
tional US.9,10 Compared with a phaco system operated
in longitudinal mode, phacoemulsification with the In-
finiti system in torsional mode was completed with less
mean phacoemulsification time (ie, the duration that
Submitted: August 11, 2015.
Final revision submitted: January 15, 2016.
Accepted: January 20, 2016.
From the Carolina Eyecare Physicians (Solomon), Charleston,
South Carolina, Alcon Research, Ltd. (Fanney), Irvine, California,
and the Eye Institute of Utah (Cionni), Salt Lake City, Utah, USA;
Complejo Hospitalario Universitario Orense (Lorente), Orense,
Spain.
Supported by Alcon Laboratories, Inc., Fort Worth, Texas, USA.
Bickol Mukesh, PhD, assisted with the statistical analyses. Medical
writing assistance was provided by Heather D. Starkey, PhD, Com-
plete Healthcare Communications, Chadds Ford, Pennsylvania,
USA, and was funded by Alcon Laboratories, Inc.
Presented in part at the ASCRS Symposium on Cataract, IOL and
Refractive Surgery, Boston, Massachusetts, USA, April 2014, and
at the XXXII Congress of the European Society of Cataract and
Refractive Surgeons, London, United Kingdom, September 2014.
Corresponding author: Kerry D. Solomon, MD, 1101 Clarity Road,
Suite 100, Mount Pleasant, South Carolina 29464, USA. E-mail:
kerry.solomon@carolinaeyecare.com.
J CATARACT REFRACT SURG - VOL 42, APRIL 2016
543
the phacoemulsification tip was in the eye) and was
associated with less postoperative corneal edema.10
The new Centurion Vision System system improves
on the fluidics of the Infiniti Vision System, and
together with the newly offered Intrepid Balanced
US tip, might lead to better surgical efficiency during
cataract procedures. The goal of this study was to
compare the intraoperative surgical efficiency metrics
(cumulative dissipated energy [CDE], aspiration time,
and aspiration fluid used) between the Centurion
system configured with the Intrepid Balanced tip
compared with the Infiniti system configured with
the standard Mini-Flared Kelman tip during routine
phacoemulsification extraction of cataracts with lens
opacities of nuclear (N) N0 to NIII, as classified by
the Lens Opacities Classification System II (LOCS II).11
PATIENTS AND METHODS
Study Design
This was a prospective randomized multicenter patient-
and clinical technician-masked 2-arm paired-eye compari-
son study performed at 2 sites in the United States and
1 site in Spain between July 2013 and February 2014 (U.S. Na-
tional Institutes of Health Clinical Trials identifier
NCT01848288).C Enrolled patients were randomized to 1 of
2 surgical configurations for first-eye surgery in a ratio of
1:1 for each surgeon. Surgeons graded cataracts before
randomization in an unmasked fashion by comparison
with standardized LOCS II photographs.11 The eye with
the worse cataract was selected as the first operative eye. If
the cataract grade was equal between eyes, the right eye
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
tip, and the 0.9 mm Intrepid Ultra infusion sleeve (Figure 1,
A). The gravity-fluidics configuration used the Infiniti Vision
System with gravity fluidics, the 0.9 mm 45-degree aspira-
tion bypass system Mini-Flared Kelman tip, and the
0.9 mm Ultra infusion sleeve (Figure 1, B). The Ozil hand-
piece (Alcon Laboratories, Inc.) was used with both surgical
configurations for all surgeries. Because all participating sur-
geons had ample experience with the Infiniti system,
whereas the Centurion system was new, all investigators
were required to have used the Centurion 100 or more times
to gain sufficient experience before study initiation.
Patients
Eligible patients provided written informed consent, were
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
planned bilateral phacoemulsification cataract extraction
with implantation of Acrysof intraocular lenses (IOLs) (Al-
con Laboratories, Inc.). Patients must have been willing to
have second-eye surgery within 14 days of first-eye surgery.
Key exclusion criteria included nuclear opalescence cataract
LOCS II grading of NIV,11 planned multiple procedures at
the time of surgery, previous intraocular or corneal surgery
(eg, refractive or therapeutic), a poorly dilating pupil or
544 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS
Figure 1. Active-fluidics (A) and gravity-fluidics (B) surgical config-
urations. Phacoemulsifier/aspirator systems, US tips, and infusion
sleeves are shown (ABS Z aspiration bypass system).
pupil defect that prevented dilation to 5.0 mm or more or a
need for mechanical or surgical manipulation to enlarge
the pupil at the time of surgery, current or previous use of
an a1-selective or an a1A-selective adrenoceptor antagonist,
diagnosis of severe retinal disorders or history of retinal
detachment, clinically significant corneal endothelial dystro-
phy, history of corneal disease, IOP greater than 21 mm Hg,
weak or broken zonular fibers, known zonular instability, or
zonular dehiscence.
Surgical Technique
Surgery was performed according to site-specific stan-
dard operating procedures: combination of divide-and-
conquer plus stop-and-chop (K.D.S.), vertical chop (R.L.),
and 4-quadrant divide-and-conquer (R.J.C.). Clear corneal
incisions of 2.2 to 2.4 mm and manually created capsulo-
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-
tient's left eye and right eye was required: Duovisc (sodium
hyaluronate 3%chondroitin sulfate 4.0% with sodium
hyaluronate 1.0%) OVD system (K.D.S., R.J.C.) and Viscoat
(sodium hyaluronate 3.0%chondroitin sulfate 4.0%)Pro-
visc (sodium hyaluronate 1.0%) combination (R.L.).
Phacoemulsification was performed using the surgical
J CATARACT REFRACT SURG - VOL 42, APRIL 2016
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%
with 80% power at a 2-sided a of 0.05.
All patients who were randomized to a surgical configura-
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
for patient demographics and preoperative characteristics,
efficiency outcomes, and safety outcomes. A random-effect
analysis of covariance model was used to test the treatment
differences in the primary and secondary efficiency out-
comes between the active-fluidics configuration and
gravity-fluidics configuration; this analysis was based on
the intent-to-treat dataset. Investigator site was included as
a covariate in the model. Analysis of the primary outcomes
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
between configurations. Analysis of the supportive outcome,
aspiration time, was performed only if both primary out-
comes were significant. Two-sided P values less than 0.05
were considered statistically significant.
RESULTS
Patients
One hundred patients were randomized to the first-
eye surgery configuration (n Z 100 eyes per configura-
tion; first-eye and second-eye surgeries combined) and
were included in the intent-to-treat dataset. Of these,
98 patients had surgery and were included in the
 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

Figure 2. Cumulative dissipated energy. Data are presented as least
squares mean G standard error. The least squares estimate of the dif-
ference between group means is shown above bars. The P value was
determined using an analysis of covariance model.
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
numerically larger in the active-fluidics configuration
( 4.3 G 5.6 mL) than in the gravity-fluidics configu-
ration ( 2.7 G 8.8 mL).

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546 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS
Figure 3. Aspiration fluid used. A: Fluid used measured by weight
(least squares mean G standard error). The least squares estimate
of the difference between group means is shown above bars. The
P value was determined using an analysis of covariance model. B:
Fluid used as estimated by each phacoemulsifier/aspirator system
compared with fluid used as measured by weight (mean G SD).
No serious ocular adverse events or device defi-
ciencies occurred. Two serious adverse events were re-
ported (1 fatal myocardial infarction and 1 infective
exacerbation of chronic obstructive airway disease);
J CATARACT REFRACT SURG - VOL 42, APRIL 2016
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-
ally a safe procedure.12 Advances in technology and
surgical techniques have shortened surgical times,
reduced the risk, and improved outcomes.10,1316 Like-
wise, phaco systems that facilitate improved surgical
efficiency with reduced active instrumentation times,
energy dissipated at the incision site, and fluid circula-
tion through the anterior chamber might further
reduce the risk for potential surgical complications.
In this contralateral-eye study, the CDE, aspiration
fluid used, and aspiration time were significantly lower
for phacoemulsification cataract surgery with the
 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-

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

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548 ACTIVE- VERSUS GRAVITY-FLUIDICS CONFIGURATIONS: INTRAOPERATIVE METRICS
experience with the Centurion Vision System, the lack
of longer experience and ideal predetermined settings
was a challenge. Assessing the surgical efficiency of
the of the new system with more experienced surgeons
and more complex cases, such as cases of brunescent
cataracts, might provide additional important data
regarding the surgical efficiency of this system. Future
studies focusing on outcome metrics, such as postop-
erative changes in central corneal thickness and endo-
thelial cell density, are needed to provide an
understanding of the clinical relevance of improved
surgical efficiency during cataract procedures.
In conclusion, the CDE, aspiration fluid used, and
aspiration time were significantly lower during phaco-
emulsification cataract extraction surgery with the
active-fluidics configuration than with the gravity-
fluidics configuration. The results in this clinical study
show that the active-fluidics configuration offers
improved surgical efficiency, with less energy deliv-
ered to the incision site, less fluid passing through
the anterior chamber into the aspiration line, and less
active surgical instrumentation time as measured by
CDE, aspiration fluid used, and aspiration time,
respectively. No serious ocular adverse events or
device deficiencies occurred, suggesting that cataract
extraction surgery with the active-fluidics configura-
tion is safe as well as efficient.
WHAT WAS KNOWN
 Phacoemulsification cataract surgery is considered a safe
procedure; however, technological advances continue to
improve patient outcomes.
WHAT THIS PAPER ADDS
 Surgery performed with the active-fluidics configuration
had less CDE, less aspiration fluid used, and less aspira-
tion time than the gravity-fluidics configuration, indicating
that surgical efficiency is improved with the active-fluidics
configuration.
 Better surgical efficiency has been associated with less
ocular trauma and better postsurgical recovery. The
active-fluidics configuration was more efficient than the
gravity-fluidics configuration system.
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