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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 phacoemulsi-
fication (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 demo-
graphics were similar between groups. There was a significant improvement in vacuum/docking at-
tempts, 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 consistent capsulotomy and a significant reduction in
allows creation of automated corneal incisions, anterior phacoemulsification energy requirements,35 have the
capsulotomy, and lens fragmentation.1 Ultrashort-pulse potential to improve refractive outcomes.
femtosecond lasers operate at near infrared wavelengths Despite reports of the safety and efficacy of femto-
and can be focused precisely at predetermined depths second laserassisted cataract surgery in a noncom-
using advanced imaging technology to photodisrupt parative large consecutive case series,6 surgeons
optically clear tissues while preventing collateral tissue remain concerned about adopting this technology
damage.2 The advantages of this technology over and about the potential learning curve.7 To date, there
conventional phacoemulsification, including a more have been no large comparative cohort or randomized

Q 2015 ASCRS and ESCRS http://dx.doi.org/10.1016/j.jcrs.2014.06.025 47


Published by Elsevier Inc. 0886-3350
48 FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION

studies in the peer-reviewed literature. In this study, Preoperatively, all patients were instructed to instill topical
we analyzed a large cohort of patients from a single ketorolac and topical chloramphenicol for the 2 days preced-
ing the procedure. After admission on the day of surgery, all
center to compare intraoperative complication rates
patients received topical anesthesia and their pupil was
between femtosecond laserassisted cataract surgery dilated with a gel formulation consisting of phenylephrine
and conventional manual phacoemulsification cata- 2.5%, cyclopentolate 1.0%, tropicamide 1.0%, lidocaine hydro-
ract surgery. chloride jelly 2.0% (Xylocaine), and diclofenac 0.1%.

PATIENTS AND METHODS Laser Parameters and Settings


This prospective consecutive comparative cohort study The Catalys Precision Laser System with a liquid-optics pa-
comprised femtosecond laserassisted cataract surgery cases tient interface (Abbott Medical Optics, Inc.) was used in the
(study group) and phacoemulsification cataract surgery study group. This diode-pumped solid-state femtosecond
cases (control group) performed at a single center between laser operates at a wavelength of 1030 nm and pulse duration
May 2012 and November 2013. The study conformed to of 600 fs. The laser settings were consistent for the duration of
the Declaration of Helsinki and its subsequent revisions, the study. The software versions were up to date at the time of
and ethics approval was obtained from the Tasmanian the study. Corneal incision modules were installed with a soft-
Human Research and Ethics Committee (HREC H12534). ware upgrade in December 2012, which reduced the time
Patients who had no contraindications to femtosecond taken for anterior capsulotomy. For corneal incisions, the
laserassisted cataract surgery were offered the surgery at main wound and 2 side-port settings, respectively, were as fol-
an out-of-pocket cost of A$750. Contraindications included lows: limbal offsets 0.3 mm and 0.4 mm, width 2.7 mm and 1.3
age younger than 22 years, extensive corneal scarring, mm, length 1.8 mm and 1.2 mm, and pulse energy 5 mJ and 6
corneal ring inlays, past glaucoma filtration surgery, and mJ. The other settings were anterior plane depth 40%, posterior
previous refractive surgery. Patients with ocular comorbid- plane depth 70%, anterior side-cut angle 75 degrees, and pos-
ities that were unlikely to affect surgical performance were terior side-cut angle 45 degrees for the main wound and the
included in the study. Eyes with previous trauma or deemed side port. For anterior capsulotomy, the incision depth was
likely to be challenging (eg, small pupil, floppy-iris syn- 600 mm, the horizontal spot spacing was 5 mm, the vertical
drome, intumescent cataract) were more likely to have spot spacing was 10 mm, and the pulse energy was 4 mJ. For
manual phacoemulsification cataract surgery based on sur- lens fragmentation, the posterior capsule safety zone was
geon preference, although these factors were relative contra- 500 mm, the horizontal spot spacing was 10 mm, the vertical
indications to femtosecond laserassisted cataract surgery spot spacing was 40 mm, and the pulse energy was 8 mJ anteri-
only. orly and 10 mJ posteriorly.

Preoperative Assessment Surgical Technique


All patients had a comprehensive baseline preoperative Cataract surgery was performed by 1 of 5 surgeons. In the
assessment. Anterior segment examinations and posterior study group, the femtosecond laser portion was performed
segment examinations were performed with undilated in a separate room adjacent to the operating room. Prede-
pupils and dilated pupils, respectively. Biometry was per- fined surgeon templates were used for the selection of
formed a maximum of 6 months before surgery. Axial anterior capsulotomy and lens fragmentation patterns. All
length, anterior chamber depth, and biometry were deter- surgeons performed 10 accreditation cases before the begin-
mined using partial coherence interferometry (IOLMaster ning of the study. Lens fragmentation patterns were altered
4, Carl Zeiss Meditec AG). Other evaluations included opti- during later cases to permit analysis of improvements in ease
cal coherence tomography (OCT) (Stratus, Carl Zeiss Medi- of cataract extraction. The surgeon confirmed the accuracy,
tec AG), specular microscopy (EM-3000, Tomey Corp.), location, and size of the corneal incisions, anterior capsulot-
corneal pachymetry with a Scheimpflug imaging system omy, and lens fragmentation architecture before laser treat-
(Pentacam, Oculus Optikgerate GmbH), and corneal topog- ment using high-resolution video and anterior segment
raphy (OPD-Scan II, Nidek Co., Ltd.). The Scheimpflug im- spectral-domain OCT imaging. The OCT imaging also al-
aging system was used to objectively assess the cataract lowed the detection of posterior capsule and iris margin
grade.8 The system uses densitometry software to evaluate safety zones. After the laser procedure, the number of vac-
lens volume and optical density and grade cataracts on a nu- uum attempts, docking attempts, troubles with vacuum or
cleus staging scale of 0 to 5. docking, treatment time, vacuum time, and OCT adjust-
ments required were recorded. The patient was then trans-
ferred to the operating room for regional anesthesia and
completion of surgery.
Submitted: February 9, 2014. Intraoperatively, corneal incisions were opened using a
Final revision submitted: June 16, 2014. flap lifter (6-858 Stevens Femto Flap Lifter, Duckworth &
Accepted: June 17, 2014. 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
From the Tasmanian Eye Institute (Abell, Darian-Smith, Kan, Allen, group. The anterior chamber was filled with sodium hyalur-
Ewe, Vote) and the Launceston Eye Institute (Vote), Tasmania, onate 3.0%chondroitin sulfate 4.0% (Viscoat) in both
Australia. groups. In the study group, the anterior capsule was
removed using a capsulorhexis forceps following the contour
Corresponding author: Brendan J. Vote, FRANZCO, Launceston Eye of the laser capsulotomy in a continuous curvilinear fashion.
Institute, 36 Thistle Street West, Launceston 7250, Australia. Subsequently, cautious hydrodissection was performed,
E-mail: eye.vote@bigpond.net.au. ensuring the release of intracapsular gas, using low volumes

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FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION 49

of fluid, and avoiding exertion of excessive pressure through


the cannula (to prevent capsule block). In the control group, Table 1. Comparison of laser procedure parameters between
the continuous curvilinear capsulorhexis (CCC) was created first half of cases and second half of cases.
with a capsulorhexis forceps. Lens segmentation was per-
First Half Second Half
formed using a divide-and-conquer approach. Surgery was
Variable of Cases of Cases P Value
then completed in both groups using standard phacoemulsi-
fication procedures (Megatron, Geuder AG) followed by Mean vacuum 1.25 G 0.61 1.26 G 0.58 NS
intraocular lens (IOL) implantation in the capsular bag after
attempts (n)
successful removal of the lens cortex.
Mean docking 1.35 G 0.69 1.28 G 0.68 .04
Intraoperative complications were recorded on the sur-
gery report and included the presence of corneal haze attempts (n)
affecting the surgical view at any timepoint not due to a pre- OCT adjustments, n (%) 91 (12.1) 43 (5.7) .0001
existing condition, laser-induced miosis, anterior capsuloto- Mean treatment time (s) 60.8 G 14.02 54.13 G 14.76 .0001
my tag, anterior capsule tear, posterior capsule tear, Vacuum time (min:sec) 3:27 G 0:43 3:23 G 0:44 NS
posterior capsule rupture, and IOL dislocation.
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 character- corneal haze affecting the surgical field view and intra-
istics between groups, categorical data were analyzed using operative miosis was statistically significantly higher in
the Fisher exact test and continuous data using paired t tests. the study group than in the control group (P ! .001).
Differences were accepted as significant when the P value
was less than 0.05. The effective phacoemulsification time was statistically
significantly lower in the study group (P ! .0001). There
were no cases of posterior lens dislocation.
RESULTS There was no difference in the incidence of anterior
The study evaluated 4080 eyes, 1852 eyes in the study or posterior capsule tears between the first half and
group and 2228 eyes in the control group. Patient demo- second half of femtosecond laserassisted cases
graphics and baseline characteristics were similar be- (c2(1) Z 1.3, P Z .3), suggesting the learning curve
tween groups. In particular, there was no significant had little effect on these parameters.
between-group difference in ocular comorbidities, intra-
operative pupil size, cataract grade, or age of patients.
The mean age was 73.5 years G 9.5 (SD) in the study DISCUSSION
group and 72.6 G 9.6 years in the control group. Nucleus This large prospective single-center comparative
staging using the Scheimpflug system showed a mean cohort study evaluated the safety and learning curve
cataract grade of 2.81 G 0.65 in the study group and of femtosecond laserassisted cataract surgery. We
2.80 G 0.71 in the control group. One thousand thirty- found a statistically significantly higher rate of ante-
seven eyes (56%) in the study group and 1225 eyes rior capsule tears in the femtosecond laserassisted
(55%) in control group were women. cataract surgery group, and this was not related to
All aspects of the laser procedure improved with the learning curve. There was, however, no between-
surgeon experience. There was a statistically signifi- group statistically significant difference in complica-
cant improvement in docking attempts, image/OCT tions such as posterior capsule tear and dropped
surface-recognition adjustments, and treatment time nucleus, which might be considered more clinically
during the laser procedure in the second half of cases relevant for refractive outcomes and patient satisfac-
(Table 1). Some improvements reflected the benefits tion. At present, there is a need for surgical bench-
of software upgrades during the study. marks with regard to laser cataract surgery
Table 2 shows the intraoperative complications. The complications so surgeons can better inform their
incidence of anterior capsule tears and anterior capsu- patients of the risks and benefits of femtosecond
lotomy tags was statistically significantly higher in the laserassisted cataract surgery.
study group than in the control group (P ! .0001). Evidence-based guidelines for phacoemulsification
Although the incidence of posterior capsule tears was cataract surgery suggest that a capsule complication
higher in the study group, the difference between rate of less than 2.0% should be achievable.9 The
groups was not statistically significant. One case of ante- incidence of anterior capsule tear in our study was
rior capsule tear in each group extended to the posterior below this figure in the femtosecond laserassisted
capsule, requiring anterior vitrectomy; the remaining group (1.84%) but was statistically significantly higher
cases proceeded uneventfully with IOL placement in than in our phacoemulsification cataract surgery
the bag. The incidence of significant intraoperative benchmark (0.22%) after 2228 cases. Published peer-

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50 FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION

Table 2. Between-group comparison of Intraoperative complications.

Number (%)

Complication Laser Assisted (n Z 1852) Phacoemulsification (n Z 2228) P Value

Incomplete capsulotomy 21 (1.13) NA NA


Anterior capsulotomy tag 30 (1.62) 1 (0.004) .0001
Anterior capsule tear 34 (1.84) 5 (0.22) .0001
Posterior capsule tear 8 (0.43) 4 (0.18) NS
Corneal haze 12 (0.65) 1 (0.04) .0009
Unstable pupil 30 (1.65) 14 (0.65) .003
Iris hooks/Malyugin ring 5 (0.27) 1 (0.04) NS

NA Z not applicable; NS Z not significant

reviewed research studies have yet to compare the the femtosecond laserassisted group. The only
complication rates of femtosecond laserassisted cata- improvement in the second half of femtosecond
ract surgery with concurrent phacoemulsification laserassisted cataract surgery cases was a significant
cataract surgery, unlike our study of prospective reduction in anterior capsulotomy tags, which was
comparative cohorts. Case mix might account for the likely the result of a software upgrade that reduced
differences between surgeons; therefore, we recom- capsulotomy time considerably, resulting in a lower
mend using objective measures of cataract densitom- chance of aberrant pulses due to eye movements.15
etry as has been previously reported.3,8,10 This suggests that the capsule complications of femto-
In both surgery groups, none of the eyes in which a second laserassisted cataract surgery in our study
complication occurred were noted perioperatively to were not related to the surgeon learning curve but
have risk factors, such as a weak zonule, a shallow rather to other effects that may be patient- or
anterior chamber, a small pupil, high vitreous pres- surgery-related, as we have previously published.15
sure, or poor visibility during surgery.11,12 We also All cases of capsule tears were reviewed and deemed
found no difference in cataract grade and age between to occur within the normal limits of a standard phaco-
the 2 groups, and patients with complications were no emulsification procedure. In other words, no extra
more likely to be older or have denser cataracts than stress to the capsule edge or accidental/inadvertent
those without complications. pressure from instrumental movements was applied
In a study by Roberts et al.,6 femtosecond laseras- beyond what would normally be expected in a stan-
sisted cataract surgery complication rates decreased dard case.
after an initial combined learning curve of 200 cases. After more than 4000 cases, we can conclude that
The reduction in complicated cases was likely the the rate of posterior capsule tear was not statistically
result of improvements in surgeon technique and significantly different between our femtosecond
experience. In that study, anterior capsule tears were laserassisted cataract surgery and phacoemulsifica-
more likely to result from a microtag being stretched tion cataract surgery cohorts, even though the result
and torn during intracapsular manipulation, and the was numerically greater in the femtosecond laser
authors recommended switching to high magnifica- cohort. Posterior capsule tears, unlike anterior
tion and inspecting the capsule edge before proceed- capsule tears, are more likely to affect the effective
ing to phacoemulsification. A recent study by lens position and hence the refractive outcome.16
Arbisser et al.13 suggests using a CCC (central dimple They also can have a significant effect on endothelial
down) technique for removing the femtosecond cell loss, glaucoma, cystoid macular edema, endoph-
laserassisted cataract surgery capsulotomy. All sur- thalmitis, and retinal detachment when anterior vit-
geons in our study were familiar with the alterations rectomy is required and surgical time prolonged.17
in intraoperative and capsule dynamics in femto- Patient satisfaction can also be hindered when signif-
second laserassisted cataract surgery and the icant procedural complications occur. The incidence
requirement for an adjustment of surgical maneu- of posterior capsule tears in the literature varies be-
vers.3,6,14 This may have been a factor in why we tween 0% and 4%.18 Our capsule complication rate
were unable to show a learning curve effect in our appears to be below the average reported in the liter-
femtosecond laserassisted cataract surgery cohort. ature,6,19,20 suggesting femtosecond laserassisted
In fact, just over 50% of anterior radial and posterior cataract surgery is as safe as phacoemulsification
capsule tears occurred in the second half of cases in cataract surgery in terms of posterior capsule

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FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION 51

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