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ARTICLE

Femtosecond laserassisted cataract surgery


versus standard phacoemulsification
cataract surgery: Outcomes and safety
in more than 4000 cases at a single center
Robin G. Abell, MB BS, Erica Darian-Smith, Jeffrey B. Kan, MB BS, Penelope L. Allen, PhD,
Shaun Y.P. Ewe, MB BS, Brendan J. Vote, FRANZCO

PURPOSE: To compare the intraoperative complications and safety of femtosecond laserassisted


cataract surgery and conventional phacoemulsification cataract surgery.
SETTING: Single center.
DESIGN: Prospective consecutive comparative cohort case series.
METHODS: Eyes had femtosecond laserassisted cataract surgery (study group) or phacoemulsification (control group) by 1 of 5 surgeons. The technique comprised manual corneal incisions and
capsulorhexis or laserassisted anterior capsulotomy, lens fragmentation, corneal incisions,
phacoemulsification, and intraocular lens implantation.
RESULTS: The study group comprised 1852 eyes and the control group, 2228 eyes. Patient demographics were similar between groups. There was a significant improvement in vacuum/docking attempts, surface recognition adjustments, treatment, and vacuum time during the laser procedure in
the study group. Anterior capsule tears occurred in 1.84% of eyes in the study group and 0.22% of
eyes in the control group (P < .0001). There was no difference in the incidence of anterior capsule tears
between the first half and second half of laser-assisted cases. Anterior capsulotomy tags occurred in
1.62% study group eyes. There was no significant difference in posterior capsule tears between the 2
groups (0.43% versus 0.18%). The incidence of significant intraoperative corneal haze and miosis was
higher and the effective phacoemulsification time significantly lower in the study group (P < .001).
CONCLUSIONS: Significant intraoperative complications likely to affect refractive outcomes and
patient satisfaction were low overall. The 2 cataract surgery techniques appear to be equally safe.
Although anterior capsule tears remain a concern, the safety of femtosecond-assisted cataract
surgery in terms of posterior capsule complications was equal to that of phacoemulsification.
Financial Disclosure: No author has a financial or proprietary interest in any material or method
mentioned.
J Cataract Refract Surg 2015; 41:4752 Q 2015 ASCRS and ESCRS

The application of femtosecond lasers in cataract surgery


allows creation of automated corneal incisions, anterior
capsulotomy, and lens fragmentation.1 Ultrashort-pulse
femtosecond lasers operate at near infrared wavelengths
and can be focused precisely at predetermined depths
using advanced imaging technology to photodisrupt
optically clear tissues while preventing collateral tissue
damage.2 The advantages of this technology over
conventional phacoemulsification, including a more
Q 2015 ASCRS and ESCRS
Published by Elsevier Inc.

consistent capsulotomy and a significant reduction in


phacoemulsification energy requirements,35 have the
potential to improve refractive outcomes.
Despite reports of the safety and efficacy of femtosecond laserassisted cataract surgery in a noncomparative large consecutive case series,6 surgeons
remain concerned about adopting this technology
and about the potential learning curve.7 To date, there
have been no large comparative cohort or randomized
http://dx.doi.org/10.1016/j.jcrs.2014.06.025
0886-3350

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FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION

studies in the peer-reviewed literature. In this study,


we analyzed a large cohort of patients from a single
center to compare intraoperative complication rates
between femtosecond laserassisted cataract surgery
and conventional manual phacoemulsification cataract surgery.

Preoperatively, all patients were instructed to instill topical


ketorolac and topical chloramphenicol for the 2 days preceding the procedure. After admission on the day of surgery, all
patients received topical anesthesia and their pupil was
dilated with a gel formulation consisting of phenylephrine
2.5%, cyclopentolate 1.0%, tropicamide 1.0%, lidocaine hydrochloride jelly 2.0% (Xylocaine), and diclofenac 0.1%.

PATIENTS AND METHODS

Laser Parameters and Settings

This prospective consecutive comparative cohort study


comprised femtosecond laserassisted cataract surgery cases
(study group) and phacoemulsification cataract surgery
cases (control group) performed at a single center between
May 2012 and November 2013. The study conformed to
the Declaration of Helsinki and its subsequent revisions,
and ethics approval was obtained from the Tasmanian
Human Research and Ethics Committee (HREC H12534).
Patients who had no contraindications to femtosecond
laserassisted cataract surgery were offered the surgery at
an out-of-pocket cost of A$750. Contraindications included
age younger than 22 years, extensive corneal scarring,
corneal ring inlays, past glaucoma filtration surgery, and
previous refractive surgery. Patients with ocular comorbidities that were unlikely to affect surgical performance were
included in the study. Eyes with previous trauma or deemed
likely to be challenging (eg, small pupil, floppy-iris syndrome, intumescent cataract) were more likely to have
manual phacoemulsification cataract surgery based on surgeon preference, although these factors were relative contraindications to femtosecond laserassisted cataract surgery
only.

The Catalys Precision Laser System with a liquid-optics patient interface (Abbott Medical Optics, Inc.) was used in the
study group. This diode-pumped solid-state femtosecond
laser operates at a wavelength of 1030 nm and pulse duration
of 600 fs. The laser settings were consistent for the duration of
the study. The software versions were up to date at the time of
the study. Corneal incision modules were installed with a software upgrade in December 2012, which reduced the time
taken for anterior capsulotomy. For corneal incisions, the
main wound and 2 side-port settings, respectively, were as follows: limbal offsets 0.3 mm and 0.4 mm, width 2.7 mm and 1.3
mm, length 1.8 mm and 1.2 mm, and pulse energy 5 mJ and 6
mJ. The other settings were anterior plane depth 40%, posterior
plane depth 70%, anterior side-cut angle 75 degrees, and posterior side-cut angle 45 degrees for the main wound and the
side port. For anterior capsulotomy, the incision depth was
600 mm, the horizontal spot spacing was 5 mm, the vertical
spot spacing was 10 mm, and the pulse energy was 4 mJ. For
lens fragmentation, the posterior capsule safety zone was
500 mm, the horizontal spot spacing was 10 mm, the vertical
spot spacing was 40 mm, and the pulse energy was 8 mJ anteriorly and 10 mJ posteriorly.

Preoperative Assessment

Surgical Technique

All patients had a comprehensive baseline preoperative


assessment. Anterior segment examinations and posterior
segment examinations were performed with undilated
pupils and dilated pupils, respectively. Biometry was performed a maximum of 6 months before surgery. Axial
length, anterior chamber depth, and biometry were determined using partial coherence interferometry (IOLMaster
4, Carl Zeiss Meditec AG). Other evaluations included optical coherence tomography (OCT) (Stratus, Carl Zeiss Meditec AG), specular microscopy (EM-3000, Tomey Corp.),
corneal pachymetry with a Scheimpflug imaging system
(Pentacam, Oculus Optikgerate GmbH), and corneal topography (OPD-Scan II, Nidek Co., Ltd.). The Scheimpflug imaging system was used to objectively assess the cataract
grade.8 The system uses densitometry software to evaluate
lens volume and optical density and grade cataracts on a nucleus staging scale of 0 to 5.

Cataract surgery was performed by 1 of 5 surgeons. In the


study group, the femtosecond laser portion was performed
in a separate room adjacent to the operating room. Predefined surgeon templates were used for the selection of
anterior capsulotomy and lens fragmentation patterns. All
surgeons performed 10 accreditation cases before the beginning of the study. Lens fragmentation patterns were altered
during later cases to permit analysis of improvements in ease
of cataract extraction. The surgeon confirmed the accuracy,
location, and size of the corneal incisions, anterior capsulotomy, and lens fragmentation architecture before laser treatment using high-resolution video and anterior segment
spectral-domain OCT imaging. The OCT imaging also allowed the detection of posterior capsule and iris margin
safety zones. After the laser procedure, the number of vacuum attempts, docking attempts, troubles with vacuum or
docking, treatment time, vacuum time, and OCT adjustments required were recorded. The patient was then transferred to the operating room for regional anesthesia and
completion of surgery.
Intraoperatively, corneal incisions were opened using a
flap lifter (6-858 Stevens Femto Flap Lifter, Duckworth &
Kent) in the study group or manually using a 2.25 to
2.75 mm keratome and 1.20 mm side-port blade in the control
group. The anterior chamber was filled with sodium hyaluronate 3.0%chondroitin sulfate 4.0% (Viscoat) in both
groups. In the study group, the anterior capsule was
removed using a capsulorhexis forceps following the contour
of the laser capsulotomy in a continuous curvilinear fashion.
Subsequently, cautious hydrodissection was performed,
ensuring the release of intracapsular gas, using low volumes

Submitted: February 9, 2014.


Final revision submitted: June 16, 2014.
Accepted: June 17, 2014.
From the Tasmanian Eye Institute (Abell, Darian-Smith, Kan, Allen,
Ewe, Vote) and the Launceston Eye Institute (Vote), Tasmania,
Australia.
Corresponding author: Brendan J. Vote, FRANZCO, Launceston Eye
Institute, 36 Thistle Street West, Launceston 7250, Australia.
E-mail: eye.vote@bigpond.net.au.

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FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION

of fluid, and avoiding exertion of excessive pressure through


the cannula (to prevent capsule block). In the control group,
the continuous curvilinear capsulorhexis (CCC) was created
with a capsulorhexis forceps. Lens segmentation was performed using a divide-and-conquer approach. Surgery was
then completed in both groups using standard phacoemulsification procedures (Megatron, Geuder AG) followed by
intraocular lens (IOL) implantation in the capsular bag after
successful removal of the lens cortex.
Intraoperative complications were recorded on the surgery report and included the presence of corneal haze
affecting the surgical view at any timepoint not due to a preexisting condition, laser-induced miosis, anterior capsulotomy tag, anterior capsule tear, posterior capsule tear,
posterior capsule rupture, and IOL dislocation.

Table 1. Comparison of laser procedure parameters between


first half of cases and second half of cases.

Variable
Mean vacuum
attempts (n)
Mean docking
attempts (n)
OCT adjustments, n (%)
Mean treatment time (s)
Vacuum time (min:sec)

First Half
of Cases

Second Half
of Cases
P Value

1.25 G 0.61

1.26 G 0.58

1.35 G 0.69

1.28 G 0.68

91 (12.1)
43 (5.7)
60.8 G 14.02 54.13 G 14.76
3:27 G 0:43 3:23 G 0:44

NS
.04
.0001
.0001
NS

Means G SD
NS Z not significant; OCT Z optical coherence tomography

Statistical Analysis
Statistical analyses were performed using SPSS software
(version 19, International Business Machines Corp.). For
comparison of baseline demographics and clinical characteristics between groups, categorical data were analyzed using
the Fisher exact test and continuous data using paired t tests.
Differences were accepted as significant when the P value
was less than 0.05.

RESULTS
The study evaluated 4080 eyes, 1852 eyes in the study
group and 2228 eyes in the control group. Patient demographics and baseline characteristics were similar between groups. In particular, there was no significant
between-group difference in ocular comorbidities, intraoperative pupil size, cataract grade, or age of patients.
The mean age was 73.5 years G 9.5 (SD) in the study
group and 72.6 G 9.6 years in the control group. Nucleus
staging using the Scheimpflug system showed a mean
cataract grade of 2.81 G 0.65 in the study group and
2.80 G 0.71 in the control group. One thousand thirtyseven eyes (56%) in the study group and 1225 eyes
(55%) in control group were women.
All aspects of the laser procedure improved with
surgeon experience. There was a statistically significant improvement in docking attempts, image/OCT
surface-recognition adjustments, and treatment time
during the laser procedure in the second half of cases
(Table 1). Some improvements reflected the benefits
of software upgrades during the study.
Table 2 shows the intraoperative complications. The
incidence of anterior capsule tears and anterior capsulotomy tags was statistically significantly higher in the
study group than in the control group (P ! .0001).
Although the incidence of posterior capsule tears was
higher in the study group, the difference between
groups was not statistically significant. One case of anterior capsule tear in each group extended to the posterior
capsule, requiring anterior vitrectomy; the remaining
cases proceeded uneventfully with IOL placement in
the bag. The incidence of significant intraoperative

corneal haze affecting the surgical field view and intraoperative miosis was statistically significantly higher in
the study group than in the control group (P ! .001).
The effective phacoemulsification time was statistically
significantly lower in the study group (P ! .0001). There
were no cases of posterior lens dislocation.
There was no difference in the incidence of anterior
or posterior capsule tears between the first half and
second half of femtosecond laserassisted cases
(c2(1) Z 1.3, P Z .3), suggesting the learning curve
had little effect on these parameters.
DISCUSSION
This large prospective single-center comparative
cohort study evaluated the safety and learning curve
of femtosecond laserassisted cataract surgery. We
found a statistically significantly higher rate of anterior capsule tears in the femtosecond laserassisted
cataract surgery group, and this was not related to
the learning curve. There was, however, no betweengroup statistically significant difference in complications such as posterior capsule tear and dropped
nucleus, which might be considered more clinically
relevant for refractive outcomes and patient satisfaction. At present, there is a need for surgical benchmarks with regard to laser cataract surgery
complications so surgeons can better inform their
patients of the risks and benefits of femtosecond
laserassisted cataract surgery.
Evidence-based guidelines for phacoemulsification
cataract surgery suggest that a capsule complication
rate of less than 2.0% should be achievable.9 The
incidence of anterior capsule tear in our study was
below this figure in the femtosecond laserassisted
group (1.84%) but was statistically significantly higher
than in our phacoemulsification cataract surgery
benchmark (0.22%) after 2228 cases. Published peer-

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FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION

Table 2. Between-group comparison of Intraoperative complications.


Number (%)
Complication
Incomplete capsulotomy
Anterior capsulotomy tag
Anterior capsule tear
Posterior capsule tear
Corneal haze
Unstable pupil
Iris hooks/Malyugin ring

Laser Assisted (n Z 1852)

Phacoemulsification (n Z 2228)

P Value

21 (1.13)
30 (1.62)
34 (1.84)
8 (0.43)
12 (0.65)
30 (1.65)
5 (0.27)

NA
1 (0.004)
5 (0.22)
4 (0.18)
1 (0.04)
14 (0.65)
1 (0.04)

NA
.0001
.0001
NS
.0009
.003
NS

NA Z not applicable; NS Z not significant

reviewed research studies have yet to compare the


complication rates of femtosecond laserassisted cataract surgery with concurrent phacoemulsification
cataract surgery, unlike our study of prospective
comparative cohorts. Case mix might account for the
differences between surgeons; therefore, we recommend using objective measures of cataract densitometry as has been previously reported.3,8,10
In both surgery groups, none of the eyes in which a
complication occurred were noted perioperatively to
have risk factors, such as a weak zonule, a shallow
anterior chamber, a small pupil, high vitreous pressure, or poor visibility during surgery.11,12 We also
found no difference in cataract grade and age between
the 2 groups, and patients with complications were no
more likely to be older or have denser cataracts than
those without complications.
In a study by Roberts et al.,6 femtosecond laserassisted cataract surgery complication rates decreased
after an initial combined learning curve of 200 cases.
The reduction in complicated cases was likely the
result of improvements in surgeon technique and
experience. In that study, anterior capsule tears were
more likely to result from a microtag being stretched
and torn during intracapsular manipulation, and the
authors recommended switching to high magnification and inspecting the capsule edge before proceeding to phacoemulsification. A recent study by
Arbisser et al.13 suggests using a CCC (central dimple
down) technique for removing the femtosecond
laserassisted cataract surgery capsulotomy. All surgeons in our study were familiar with the alterations
in intraoperative and capsule dynamics in femtosecond laserassisted cataract surgery and the
requirement for an adjustment of surgical maneuvers.3,6,14 This may have been a factor in why we
were unable to show a learning curve effect in our
femtosecond laserassisted cataract surgery cohort.
In fact, just over 50% of anterior radial and posterior
capsule tears occurred in the second half of cases in

the femtosecond laserassisted group. The only


improvement in the second half of femtosecond
laserassisted cataract surgery cases was a significant
reduction in anterior capsulotomy tags, which was
likely the result of a software upgrade that reduced
capsulotomy time considerably, resulting in a lower
chance of aberrant pulses due to eye movements.15
This suggests that the capsule complications of femtosecond laserassisted cataract surgery in our study
were not related to the surgeon learning curve but
rather to other effects that may be patient- or
surgery-related, as we have previously published.15
All cases of capsule tears were reviewed and deemed
to occur within the normal limits of a standard phacoemulsification procedure. In other words, no extra
stress to the capsule edge or accidental/inadvertent
pressure from instrumental movements was applied
beyond what would normally be expected in a standard case.
After more than 4000 cases, we can conclude that
the rate of posterior capsule tear was not statistically
significantly different between our femtosecond
laserassisted cataract surgery and phacoemulsification cataract surgery cohorts, even though the result
was numerically greater in the femtosecond laser
cohort. Posterior capsule tears, unlike anterior
capsule tears, are more likely to affect the effective
lens position and hence the refractive outcome.16
They also can have a significant effect on endothelial
cell loss, glaucoma, cystoid macular edema, endophthalmitis, and retinal detachment when anterior vitrectomy is required and surgical time prolonged.17
Patient satisfaction can also be hindered when significant procedural complications occur. The incidence
of posterior capsule tears in the literature varies between 0% and 4%.18 Our capsule complication rate
appears to be below the average reported in the literature,6,19,20 suggesting femtosecond laserassisted
cataract surgery is as safe as phacoemulsification
cataract surgery in terms of posterior capsule

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FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION

complications. However, our results show a statistically significantly greater risk for anterior capsule
tears in femtosecond laserassisted cataract surgery
(1.84%) than in phacoemulsification cataract surgery
(0.22%). A case study of capsular block syndrome
(CBS)7 showed the potential for large volumes of intracapsular gas to cause posterior capsule rupture
during hydrodissection and hence was the first study
to report the differences in fluid volumes, fluidics, intracapsular dynamics, and their potential effect on intracapsular manipulations. Only 1 of our cases of
posterior capsule tear in the femtosecond laser group
occurred as a result of CBS and in the first handful of
cases performed by the surgeon. The surgeon was
able to remove the lens in the anterior segment plane;
this was followed by anterior vitrectomy and IOL implantation in the sulcus.
The safety of femtosecond laserassisted cataract
surgery has been reported in the short term.6 Early
studies of the short-term and long-term surgical outcomes are also emerging,2127 and there may be an effect of a learning curve that we did not identify in our
study.6,19 Further research of the effect of femtosecond
laserassisted cataract surgery on the postoperative
intraocular pressure, corneal edema, endothelial cell
count, and macular thickness may indicate whether
the reduction in phacoemulsification energy and
replacement with femtosecond laser energy will lead
to improved safety and better outcomes.
In conclusion, significant intraoperative complications that are likely to affect refractive outcomes and
patient satisfaction were low in both groups. Femtosecond laserassisted cataract surgery appears to be
as safe as conventional phacoemulsification cataract
surgery. Although anterior capsule tears remain a
concern, the safety of femtosecond laserassisted cataract surgery and phacoemulsification cataract surgery
was the same in terms of posterior capsule
complications.
WHAT WAS KNOWN
 Femtosecond laserassisted cataract surgery is as safe
and effective as conventional phacoemulsification cataract surgery.
WHAT THIS PAPER ADDS
 Anterior capsule tears remain a concern; however, the
incidence of posterior capsule complications was similar
between the 2 surgical techniques.
 The effect of a learning curve on intraoperative complications was minimal.

51

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