Femtosecond Laser–Assisted Cataract Surgery
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Femtosecond laserassisted cataract surgeryversus standard phacoemulsification
cataract surgery: Outcomes and safety
in more than 4000 cases at a single centerRobin 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 laserassistedcataract 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 andcapsulorhexis 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 inthe study group. Anterior capsule tears occurred in 1.84% of eyes in the study group and 0.22% ofeyes in the control group (P< .0001). There wasno differencein the incidence of anterior capsule tearsbetween 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 2groups(0.43% versus0.18%). The incidence of significant intraoperative corneal haze andmiosiswashigher and the effective phacoemulsification time significantly lower in the study group (P< .001).
CONCLUSIONS: Significant intraoperative complications likely to affect refractive outcomes andpatient 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 cataractsurgery 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 methodmentioned.
J Cataract Refract Surg 2015; 41:4752Q 2015 ASCRS and ESCRS
Theapplication of femtosecond lasers in cataract surgeryallows creation of automated cornealincisions, anteriorcapsulotomy, and lens fragmentation.1 Ultrashort-pulsefemtosecond lasers operate at near infrared wavelengthsand can be focused precisely at predetermined depthsusing advanced imaging technology to photodisruptoptically clear tissues while preventing collateral tissuedamage.2 The advantages of this technology overconventional phacoemulsification, including a more
consistent capsulotomy and a significant reduction inphacoemulsification energy requirements,35 have thepotential to improve refractive outcomes.
Despite reports of the safety and efficacy of femto-second laserassisted cataract surgery in a noncom-parative large consecutive case series,6 surgeonsremain concerned about adopting this technologyand about the potential learning curve.7 To date, therehave been no large comparative cohort or randomized
Q2015 ASCRS and ESCRS
Published by Elsevier Inc.
http://dx.doi.org/10.1016/j.jcrs.2014.06.025 470886-3350
ARTICLE
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studies in the peer-reviewed literature. In this study,we analyzed a large cohort of patients from a singlecenter to compare intraoperative complication ratesbetween femtosecond laserassisted cataract surgeryand conventional manual phacoemulsification cata-ract surgery.
PATIENTS AND METHODS
This prospective consecutive comparative cohort studycomprised femtosecond laserassisted cataract surgery cases(study group) and phacoemulsification cataract surgerycases (control group) performed at a single center betweenMay 2012 and November 2013. The study conformed tothe Declaration of Helsinki and its subsequent revisions,and ethics approval was obtained from the TasmanianHuman Research and Ethics Committee (HREC H12534).
Patients who had no contraindications to femtosecondlaserassisted cataract surgery were offered the surgery atan out-of-pocket cost of A$750. Contraindications includedage younger than 22 years, extensive corneal scarring,corneal ring inlays, past glaucoma filtration surgery, andprevious refractive surgery. Patients with ocular comorbid-ities that were unlikely to affect surgical performance wereincluded in the study. Eyes with previous trauma or deemedlikely to be challenging (eg, small pupil, floppy-iris syn-drome, intumescent cataract) were more likely to havemanual phacoemulsification cataract surgery based on sur-geon preference, although these factors were relative contra-indications to femtosecond laserassisted cataract surgeryonly.
Preoperative Assessment
All patients had a comprehensive baseline preoperativeassessment. Anterior segment examinations and posterior
segment examinations were performed with undilatedpupils and dilated pupils, respectively. Biometry was per-formed a maximum of 6 months before surgery. Axiallength, anterior chamber depth, and biometry were deter-mined using partial coherence interferometry (IOLMaster4, Carl Zeiss Meditec AG). Other evaluations included opti-cal coherence tomography (OCT) (Stratus, Carl Zeiss Medi-tec AG), specular microscopy (EM-3000, Tomey Corp.),corneal pachymetry with a Scheimpflug imaging system(Pentacam, Oculus Optikgerate GmbH), and corneal topog-raphy (OPD-Scan II, Nidek Co., Ltd.). The Scheimpflug im-aging system was used to objectively assess the cataractgrade.8 The system uses densitometry software to evaluatelens volume and optical density and grade cataracts on a nu-cleus staging scale of 0 to 5.
Preoperatively, all patients were instructed to instill topicalketorolac and topical chloramphenicol for the 2 days preced-ing the procedure. After admission on the day of surgery, allpatients received topical anesthesia and their pupil wasdilated with a gel formulation consisting of phenylephrine2.5%, cyclopentolate 1.0%, tropicamide1.0%, lidocaine hydro-chloride jelly 2.0% (Xylocaine), and diclofenac 0.1%.
Laser Parameters and Settings
The Catalys Precision Laser System with a liquid-optics pa-tient interface (Abbott Medical Optics, Inc.) was used in thestudy group. This diode-pumped solid-state femtosecondlaser operates at a wavelength of 1030 nm and pulse durationof 600 fs. The laser settings were consistent for the duration ofthe study. The software versions were up to date at thetime ofthe study. Corneal incision moduleswere installedwitha soft-ware upgrade in December 2012, which reduced the timetaken for anterior capsulotomy. For corneal incisions, themain wound and 2 side-port settings, respectively, were as fol-lows: limbal offsets 0.3mm and 0.4mm, width2.7 mm and 1.3mm, length 1.8 mm and 1.2 mm, and pulse energy 5 mJ and 6mJ. The other settingswere anterior plane depth 40%, posteriorplane depth 70%, anterior side-cut angle 75 degrees, and pos-terior side-cut angle 45 degrees for the main wound and theside port. For anterior capsulotomy, the incision depth was600 mm, the horizontal spot spacing was 5 mm, the verticalspot spacing was 10 mm, and the pulse energy was 4 mJ. Forlens fragmentation, the posterior capsule safety zone was500 mm, the horizontal spot spacing was 10 mm, the verticalspot spacing was 40mm, and the pulse energy was 8 mJ anteri-orly and 10 mJ posteriorly.
Surgical Technique
Cataract surgery was performed by 1 of 5 surgeons. In thestudy group, the femtosecond laser portion was performed
in a separate room adjacent to the operating room. Prede-fined surgeon templates were used for the selection ofanterior capsulotomy and lens fragmentation patterns. Allsurgeons performed 10 accreditation cases before the begin-ning of the study. Lens fragmentation patterns were alteredduring later cases to permit analysis of improvements in easeof cataract extraction. The surgeon confirmed the accuracy,location, and size of the corneal incisions, anterior capsulot-omy, and lens fragmentation architecture before laser treat-ment using high-resolution video and anterior segmentspectral-domain OCT imaging. The OCT imaging also al-lowed the detection of posterior capsule and iris marginsafety zones. After the laser procedure, the number of vac-uum attempts, docking attempts, troubles with vacuum ordocking, treatment time, vacuum time, and OCT adjust-
ments required were recorded. The patient was then trans-ferred to the operating room for regional anesthesia andcompletion of surgery.
Intraoperatively, corneal incisions were opened using aflap lifter (6-858 Stevens Femto Flap Lifter, Duckworth &Kent) in the study group or manually using a 2.25 to2.75 mm keratome and1.20 mm side-portblade in the controlgroup. The anterior chamber was filled with sodium hyalur-onate 3.0%chondroitin sulfate 4.0% (Viscoat) in bothgroups. In the study group, the anterior capsule wasremoved using a capsulorhexis forceps following the contourof 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 EyeInstitute, 36 Thistle Street West, Launceston 7250, Australia.E-mail:[email protected].
48 FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION
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of fluid, and avoiding exertion of excessive pressure throughthe cannula (to prevent capsule block). In the control group,the continuous curvilinear capsulorhexis (CCC) was createdwith a capsulorhexis forceps. Lens segmentation was per-formed using a divide-and-conquer approach. Surgery wasthen completed in both groups using standard phacoemulsi-fication procedures (Megatron, Geuder AG) followed byintraocular lens (IOL) implantation in the capsular bag after
successful removal of the lens cortex.Intraoperative complications were recorded on the sur-
gery report and included the presence of corneal hazeaffecting the surgical view at any timepoint not due to a pre-existing condition, laser-induced miosis, anterior capsuloto-my tag, anterior capsule tear, posterior capsule tear,posterior capsule rupture, and IOL dislocation.
Statistical Analysis
Statistical analyses were performed using SPSS software(version 19, International Business Machines Corp.). Forcomparison of baseline demographics and clinical character-istics between groups, categorical data were analyzed using
the Fisher exact test and continuous data using paired ttests.Differences were accepted as significant when the P valuewas less than 0.05.
RESULTS
The study evaluated 4080 eyes, 1852 eyes in the studygroup and 2228 eyes in the control group. Patient demo-graphics and baseline characteristics were similar be-tween groups. In particular, there was no significantbetween-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
groupand72.6G 9.6years in thecontrol group.Nucleusstaging using the Scheimpflug system showed a meancataract grade of 2.81 G 0.65 in the study group and2.80G 0.71 in the control group. One thousand thirty-seven eyes (56%) in the study group and 1225 eyes(55%) in control group were women.
All aspects of the laser procedure improved withsurgeon experience. There was a statistically signifi-cant improvement in docking attempts, image/OCTsurface-recognition adjustments, and treatment timeduring the laser procedure in the second half of cases(Table 1). Some improvements reflected the benefits
of software upgrades during the study.Table 2shows the intraoperative complications. Theincidence of anterior capsule tears and anterior capsu-lotomy tags was statistically significantly higher in thestudy group than in the control group (P ! .0001).Although the incidence of posterior capsule tears washigher in the study group, the difference betweengroupswasnot statistically significant. Onecaseof ante-rior capsule tear in each group extended to theposteriorcapsule, requiring anterior vitrectomy; the remainingcases proceeded uneventfully with IOL placement inthe bag. The incidence of significant intraoperative
corneal haze affecting the surgical field view and intra-operative miosis was statistically significantly higher in
the study group than in the control group (P ! .001).The effective phacoemulsification time was statisticallysignificantlylower in thestudy group (P! .0001). Therewere no cases of posterior lens dislocation.
There was no difference in the incidence of anterioror posterior capsule tears between the first half andsecond half of femtosecond laserassisted cases(c2(1) Z 1.3, P Z .3), suggesting the learning curvehad little effect on these parameters.
DISCUSSION
This large prospective single-center comparativecohort study evaluated the safety and learning curveof femtosecond laserassisted cataract surgery. Wefound a statistically significantly higher rate of ante-rior capsule tears in the femtosecond laserassistedcataract surgery group, and this was not related tothe learning curve. There was, however, no between-group statistically significant difference in complica-tions such as posterior capsule tear and droppednucleus, which might be considered more clinicallyrelevant for refractive outcomes and patient satisfac-tion. At present, there is a need for surgical bench-
marks with regard to laser cataract surgerycomplications so surgeons can better inform theirpatients of the risks and benefits of femtosecondlaserassisted cataract surgery.
Evidence-based guidelines for phacoemulsificationcataract surgery suggest that a capsule complicationrate of less than 2.0% should be achievable.9 Theincidence of anterior capsule tear in our study wasbelow this figure in the femtosecond laserassistedgroup (1.84%) but was statistically significantly higherthan in our phacoemulsification cataract surgerybenchmark (0.22%) after 2228 cases. Published peer-
Table 1. Comparison of laser procedure parameters betweenfirst half of cases and second half of cases.
VariableFirst Halfof Cases
Second Halfof Cases PValue
Mean vacuum
attempts (n)
1.25G 0.61 1.26G 0.58 NS
Mean docking
attempts (n)
1.35G 0.69 1.28G 0.68 .04
OCT adjustments, n (%) 91 (12.1) 43 (5.7) .0001
Mean treatment time (s) 60.8 G 14.02 54.13G 14.76 .0001
Vacuum time (min:sec) 3:27G 0:43 3:23G 0:44 NS
MeansG SD
NSZ not significant; OCTZ optical coherence tomography
49FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION
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reviewed research studies have yet to compare thecomplication rates of femtosecond laserassisted cata-ract surgery with concurrent phacoemulsificationcataract surgery, unlike our study of prospective
comparative cohorts. Case mix might account for thedifferences between surgeons; therefore, we recom-mend using objective measures of cataract densitom-etry as has been previously reported.3,8,10
In both surgery groups, none of the eyes in which acomplication occurred were noted perioperatively tohave risk factors, such as a weak zonule, a shallowanterior chamber, a small pupil, high vitreous pres-sure, or poor visibility during surgery.11,12 We alsofound no difference in cataract grade and age betweenthe 2 groups, and patients with complications were nomore likely to be older or have denser cataracts than
those without complications.In a study by Roberts et al.,6 femtosecond laseras-
sisted cataract surgery complication rates decreasedafter an initial combined learning curve of 200 cases.The reduction in complicated cases was likely theresult of improvements in surgeon technique andexperience. In that study, anterior capsule tears weremore likely to result from a microtag being stretchedand torn during intracapsular manipulation, and theauthors recommended switching to high magnifica-tion and inspecting the capsule edge before proceed-ing to phacoemulsification. A recent study by
Arbisser et al.13
suggests using a CCC (central dimpledown) technique for removing the femtosecondlaserassisted cataract surgery capsulotomy. All sur-geons in our study were familiar with the alterationsin intraoperative and capsule dynamics in femto-second laserassisted cataract surgery and therequirement for an adjustment of surgical maneu-vers.3,6,14 This may have been a factor in why wewere unable to show a learning curve effect in ourfemtosecond laserassisted cataract surgery cohort.In fact, just over 50% of anterior radial and posteriorcapsule tears occurred in the second half of cases in
the femtosecond laserassisted group. The onlyimprovement in the second half of femtosecondlaserassisted cataract surgery cases was a significantreduction in anterior capsulotomy tags, which was
likely the result of a software upgrade that reducedcapsulotomy time considerably, resulting in a lowerchance of aberrant pulses due to eye movements.15
This suggests that the capsule complications of femto-second laserassisted cataract surgery in our studywere not related to the surgeon learning curve butrather to other effects that may be patient- orsurgery-related, as we have previously published.15
All cases of capsule tears were reviewed and deemedto occur within the normal limits of a standard phaco-emulsification procedure. In other words, no extrastress to the capsule edge or accidental/inadvertent
pressure from instrumental movements was appliedbeyond what would normally be expected in a stan-dard case.
After more than 4000 cases, we can conclude thatthe rate of posterior capsule tear was not statisticallysignificantly different between our femtosecondlaserassisted cataract surgery and phacoemulsifica-tion cataract surgery cohorts, even though the resultwas numerically greater in the femtosecond lasercohort. Posterior capsule tears, unlike anteriorcapsule tears, are more likely to affect the effectivelens position and hence the refractive outcome.16
They also can have a significant effect on endothelialcell loss, glaucoma, cystoid macular edema, endoph-thalmitis, and retinal detachment when anterior vit-rectomy is required and surgical time prolonged.17
Patient satisfaction can also be hindered when signif-icant procedural complications occur. The incidenceof posterior capsule tears in the literature varies be-tween 0% and 4%.18 Our capsule complication rateappears to be below the average reported in the liter-ature,6,19,20 suggesting femtosecond laserassistedcataract surgery is as safe as phacoemulsificationcataract surgery in terms of posterior capsule
Table 2. Between-group comparison of Intraoperative complications.
Number (%)
Complication Laser Assisted (n Z 1852) Phacoemulsification (n Z 2228) PValue
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
NAZ not applicable; NS Z not significant
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complications. However, our results show a statisti-cally significantly greater risk for anterior capsuletears 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 in-tracapsular gas to cause posterior capsule ruptureduring hydrodissection and hence was the first studyto report the differences in fluid volumes, fluidics, in-tracapsular dynamics, and their potential effect on in-tracapsular manipulations. Only 1 of our cases ofposterior capsule tear in the femtosecond laser groupoccurred as a result of CBS and in the first handful ofcases performed by the surgeon. The surgeon wasable to remove the lens in the anterior segment plane;this was followed by anterior vitrectomy and IOL im-plantation in the sulcus.
The safety of femtosecond laserassisted cataractsurgery has been reported in the short term.6 Early
studies of the short-termandlong-term surgical out-comes are also emerging,2127 and there may be an ef-fect ofa learning curve that we did not identify in ourstudy.6,19 Further research of the effect of femtosecondlaserassisted cataract surgery on the postoperativeintraocular pressure, corneal edema, endothelial cellcount, and macular thickness may indicate whetherthe reduction in phacoemulsification energy andreplacement with femtosecond laser energy will leadto improved safety and better outcomes.
In conclusion, significant intraoperative complica-tions that are likely to affect refractive outcomes and
patient satisfaction were low in both groups. Femto-second laserassisted cataract surgery appears to beas safe as conventional phacoemulsification cataractsurgery. Although anterior capsule tears remain aconcern, the safety of femtosecond laserassisted cata-ract surgery and phacoemulsification cataract surgerywas the same in terms of posterior capsulecomplications.
WHAT WAS KNOWN
Femtosecond laserassisted cataract surgery is as safe
and effective as conventional phacoemulsification cata-ract 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 complica-
tions was minimal.
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51FEMTOSECOND LASER VERSUS PHACOEMULSIFICATION
J CATARACT REFRACT SURG - VOL 41, JANUARY 2015
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