www.eyeworld.org

The News Magazine of the American Society of Cataract and Refractive Surgery

“ The spectrum of IOL and lasertechnology at our disposal is broaderand richer than ever. We can deliverexcellent results by carefully tailoringthe various surgical options to theindividual needs of our patients.”

Steven J. Dell, M.D.

Premium Clinical Options forCataract & Refractive Surgery

CONTRIBUTORS

Jack T. Holladay, M.D.Perry S. Binder, M.D.Steven C. Schallhorn, M.D.David J. Tanzer, M.D.William B. Trattler, M.D.Marguerite B. McDonald, M.D.Eric D. Donnenfeld, M.D.Roger F. Steinert, M.D.Farrell C. Tyson, M.D.Donald R. Nixon, M.D.

Supported by an educational grant from Abbott Medical Optics

S U P P L EM E N T T O E Y EWOR L D MAY 2 0 0 9

Refractive CataractTechnologiesPages 8–11

Ocular SurfaceManagementPage 7

Laser VisionCorrectionPages 2–6

2 Premium Clinical Options for Cataract & Refractive Surgery

The goal of customized LASIK is toreduce all higher-order aberrations

Fewer high-order aberrationsyields better visual performance

by Jack T. Holladay, M.D.

Arecent study demon-strates that the wave-front-guided LASIK pro-cedure induces signifi-cantly less higher-order

aberrations, spherical aberration,trefoil, and coma than the wave-front-optimized LASIK procedure.In some cases, wavefront-opti-mized LASIK induced aberrations.Thus, wavefront-guided ablationsprovide the best results for thevast majority of patients with thelowest rate of retreatment overconventional LASIK and wave-front-optimized LASIK.

Reducing aberrationsStudies show that less higher-orderaberrations in the eye result inbetter quality of vision. In the lab-oratory, Pablo Artal, Ph.D., showedeliminating all higher-order aber-rations produces the best visualperformance. In addition, studiesfrom Steve Schallhorn, M.D.,global medical director of OpticalExpress, with 140 pilots and 228clinic patients showed that thebest visual performance occurredwith the lowest amount of higher-order aberrations. Similarly, pilotswho had never had surgery natu-rally had lower higher-order aber-rations.

With wavefront-optimizedLASIK, the goal is not to reducethe spherical aberration, but sim-ply not increase it. The treatmentbasis is sphere and cylinder.Optimized simply means “notintended to induce spherical aber-ration,” and therefore does notaddress pre-op spherical aberrationor any other higher-order aberra-tions. Numerous studies haveshown that by the time mostpatients reach their 40s, they havepositive ocular spherical aberra-tions. With wavefront-guidedLASIK, the goal is to reduce allhigher-order aberrations. Thespherical aberration target is zero.

Study and resultsThe purpose of our study was tocompare wavefront-optimized andwavefront-guided procedures todetermine which is more effective.The retrospective chart reviewstudy of 200 IntraLASIK proce-dures included 100+ IntraLase(Abbott Medical Optics, AMO,Santa Ana, Calif.) Wavelight(wavefront-optimized) eyes and100+ IntraLase CustomVue (AMO)(wavefront-guided) eyes. Pre-opand post-op wavefront scans weredone on all eyes at a 6-mm pupilsize. Primary spherical aberrations,

“We have foundthat wavefront-guided LASIK hasthe best chanceof maintaining orimproving higher-order aberra-tions, and there-fore has the bestchance of provid-ing optimal visualquality.”

Jack T. Holladay, M.D.

primary coma, primary trefoil, andtotal higher-order aberrations weremeasured.

One hundred and nineCustomVue eyes and 102Wavelight eyes were reviewed in2006 and early 2007. These studyresults show that wavefront-guid-ed ablation with femtosecondtechnology is optimal for themajority of patients.

Overall, the wavefront-guidedtreatment induces significantlyless higher-order aberrations,spherical aberration, trefoil, andcoma than the wavefront-opti-mized procedure (Figure 1 and 2).There was significantly more varia-tion with the wavefront-optimizedeyes. This study indicates that forall higher-order aberration in thewavefront-guided group, about12% of patients were better, 76%

were the same, and 12% wereworse post-op. With wavefront-optimized, about 8% were better,51% were the same, and 41% wereworse. There was significantlygreater safety for the patients withthe guided procedure. The wave-front-guided procedure had thegreater efficacy for total higher-order aberrations and the bettersafety with the lowest inducedaberrations.

We have found that wave-front-guided LASIK has the bestchance of maintaining or improv-ing higher order aberrations, andtherefore has the best chance ofproviding optimal visual quality.

Dr. Holladay is clinical professorof ophthalmology at Baylor Collegeof Medicine in Houston, Texas.Contact him at holladay@docholladay.com.

Figure 1: Wavefront-guided ablations were shown to improve or have no change on higher-order aberrations (HOA) in 88% of all patients in the study

Figure 2: Wavefront-optimized ablations worsened higher-order aberrations (HOA) in 41% ofall patients treated in the study, compared to 12% with wavefront-guided ablations

In an independent retrospective analysis of 721 eyes treated onthree lasers, CustomVue produced excellent results

Comparing conventional, custom,and wavefront-optimized LASIK

by Perry S. Binder, M.D.

Not long ago I retrospective-ly analyzed my LASIK out-comes to try to determinewhich laser algorithm pro-vided my patients with

the best results1.At the time, we were using

three laser platforms in our clinicalrefractive surgery practice. Wecompared a total of 721 eyes of458 myopic patients across fivetreatment groups: Visx Star con-ventional and wavefront-guided,CustomVue (Abbott MedicalOptics, AMO, Santa Ana, Calif.);LADARVision conventional andwavefront-guided (Alcon, FortWorth, Texas); and Allegretto Wavewavefront-optimized (Alcon).Spheres and spherocylindrical eyeswere analyzed separately.

I personally performed all theablations and used the IntraLasefemtosecond laser in every case, sothe microkeratome and surgeonwere constant. Iris Registrationand Fourier-based wavefrontanalysis was not available at thattime. I marked the corneas at theslit lamp for all conventional caseswith greater than 0.5 D of astig-matism and for all custom cases.

In all cases, aberrometry wasobtained pre- and post-op (using

the same aberrometer both times)without regard to whether thepatient had a custom ablation.

Mean follow up for the variousgroups ranged from 1 to 26months. Stratification by pupil size(≤ 6.5 mm or > 6.5 mm) did notchange any of the conclusions.

All of the lasers performedwell. They all improved uncorrect-ed and best-corrected visual acuityand produced very predictablerefractive change. Visx CustomVueproduced the best UCVA results inspheres, with 41.7% seeing 20/16or better, while the Allegretto laserproduced the best UCVA results inspherocylinders, with 30% achiev-ing UCVA of 20/16 or better. Table1 provides a summary of statisti-cally significant results.

Overall, the Visx wavefront-guided ablations improved resultscompared to conventional Visxtreatments. LadarVision wavefrontablations did not improve on con-ventional results.

All of the lasers induced high-er-order aberrations (HOA).However, those patients withgreater pre-op HOA did better witheither a wavefront-guided or wave-front-optimized treatment thanwith a conventional one. Visx

CustomVue produced the bestHOA results in terms of total RMSand change in RMS, for bothspheres and spherocylinders.

Interestingly, the AllegrettoWave platform produced the worstspherical aberration (SA) results ofany group, even though theAllegretto’s wavefront-optimizedalgorithm is designed to reducethe induction of SA. Sphericalaberration is the most commonlyinduced HOA and the one thatseems to cause the greatest prob-lems with visual quality. Althoughthe Allegretto laser performed wellin terms of visual acuity, it did notreduce the induction of SA.

Following this study, I signifi-cantly increased the percentage ofVisx CustomVue cases I perform,given the favorable across-the-board results in that group.

Dr. Binder was not a consultant for any of thelaser manufacturers at the time the study wasperformed. Contact him at 858-455-6800 orpsbinder@gbvision.com.

1. Binder P, Rosenshein J. Retrospectivecomparison of 3 laser platforms tocorrect myopic spheres and sphero-cylinders using conventional versuswavefront-guided LASIK. J CataractRefract Surg 2007;33(7):1158-76.

“ Following thisstudy, I signifi-cantly increasedthe percentage ofVisx CustomVuecases I perform,given the favor-able across-the-board results inthat group.”

Perry S. Binder, M.D.

Laser Vision Correction 3

Figure 1: VISX CustomVue provided the best outcomes in most categories, including UCVA and BSCVA, for sphere-only eyesin the study

Wavefront-guided LASIK with the femtosecond laseryields safe, positive results with minimal complications

Large-scale study validates positive LASIK results

by Steven C. Schallhorn, M.D.

Results from a large clinicalevaluation of refractivesurgery reconfirm laservision correction (LVC) asa safe and effective sur-

gery to correct refractive errorswith a low complication rate.

A retrospective review of safetyand efficacy was recently conduct-ed of Optical Express, which hasover 200 locations and is Europe’slargest provider of LVC, to evalu-ate surgical outcomes in a largecorporate practice. Optical Expressuses a multi-disciplinary patientcare model with surgeons,optometrists, and their supportstaff who appropriately sharepatient care responsibilities.

The study includes data onconsecutive, recently performedLASIK and LASEK procedures(49,011 eyes of 24,505 patients)for the treatment of myopia,hyperopia, and astigmatism whereemmetropia was the goal. Patientsreceived treatments with the STARS4IR excimer laser system (AbbottMedical Optics, AMO, Santa Ana,Calif.). Either the IntraLase FS-60(AMO) or the Moria single-usemicrokeratome (Moria, Antony,France) was used to create theLASIK flaps. An alcohol solutionwas used to remove epithelium inLASEK cases. The mean pre-opsphere was –2.97 D for myopesand +2.34 D for hyperopes.

Corrections ranged from –12.00 Dto +6.00 D. The mean pre-opcylinder was –0.76 D.

Study findingsLASIK was performed in 91% ofpatients while 9% received LASEK.Despite the added cost, mostpatients (80%) selected a wave-front-guided ablation profile(WFG, Advanced CustomVue) andmost LASIK patients (70%) select-ed the femtosecond laser for theirmethod of flap creation. Thisdemonstrates an increasing publicacceptance of the benefits of thisadvanced laser vision correctiontechnology.

Most patients (92%) returnedfor their one-month follow-upexamination. The mean one-month manifest spherical equiva-lent (MSE) of the entire cohort was–0.08 D. Eighty-five percent ofeyes were within 0.5 D, and 97%of eyes were within 1.0 D of theirintended correction (emmetropia).Bearing in mind the wide range ofpre-op refractive error, the inclu-sion of LASEK, and the relativelyearly post-op time period, the one-month uncorrected visual acuity(UCVA) was excellent, as 86% ofeyes treated for myopia and 61%of eyes with pre-op hyperopiaachieved 20/20 UCVA (Figure 1).Further, for the entire cohort ofpatients who had bilateral laser

vision correction, 93% achieved20/20 or better uncorrected binoc-ular vision. There was an averageof nine lines gained in post-opUCVA compared to pre-op. Nearlyall eyes reached 20/40. The loss ofmore than two lines of best cor-rected vision (BCVA) was 0.35%,and there was no difference in themean post-op BCVA compared topre-op. Continued improvementin uncorrected and best correctedvision is expected beyond onemonth post-op.

Low complicationsThe overall complication rate wasvery low (0.8%) and includedmany of the complications report-ed in the literature. Most compli-cations (dry eye, DLK, flap striae,and transient light sensitivity, etc.)were successfully treated withoutlong-term adverse effects. Thisreconfirms the safety of LVC.

Overall, LASIK flap complica-tions were rare. While most of theflaps were created with the fem-tosecond laser, most of the flapcomplications, such as buttonholeand incomplete flaps, occurredwith the mechanical keratome.This underscores the safety advan-tage of the femtosecond laser.

Dr. Schallhorn is the global medical directorfor Optical Express and the past Director ofRefractive Surgery for the U.S. Navy. Contacthim at steveschallhorn@opticalexpress.com.

4 Premium Clinical Options for Cataract & Refractive Surgery

“ Despite theadded cost, mostpatients selectedfemtosecond flapcreation and aWFG ablationprofile for theirlaser visioncorrection. Thisdemonstrates anincreasing publicacceptance ofthe benefits ofthis advancedlaser visioncorrectiontechnology.””

Steven C. Schallhorn, M.D.

Figure 1: One-month uncorrected acuity in 45,090 eyes treated with either LASIK or LASEK for pre-op sphere rangingfrom –12.00 to +6.00 D

Laser Vision Correction 5

Early data with the iLASIK technology used innaval aviation shows excellent post-op vision

Bringing LASIK to the next level

by David J. Tanzer, M.D., CAPT, MC (FS), USN

Preliminary results from astudy on the first 32 eyesusing the 5th generationfemtosecond laser (iFSlaser, Abbott Medical

Optics, AMO, Santa Ana, Calif.) atour facility showed improved out-comes over the FS 60kHz, with97% of patients achieving 20/20UCVA at day one and 100% atweek one (Figure 1).

Next generationAdvancements with the new fem-tosecond laser, including theinverted side-cut architecture andelliptical flap-making capabilities,bring LASIK to the next level. Wereceived our iFS in the beginningof January 2009 and have beenusing it exclusively since thenwith wavefront-guided ablations(CustomVue iLASIK). Our initialimpressions were that the visuali-zation of treatment through theflat screen monitor is significantlybetter than the optics of themicroscope in the type II Intralase,the FS 60kHz. The flat screen mon-itor allows the surgeon to focus,adjust illumination, togglebetween light eye and dark eyesettings, and utilize customizablepreset settings.

Our early results of the first 32eyes have been excellent. Themean pre-op MRx was –2.00 D,with a range of –0.86 to –4.58. Wecompared this to 135 eyes with amean pre-op MRx of –2.41 D, witha range of –0.54 to –6.94. Ninety-seven percent of patients in theiFS group achieved 20/20 UCVA atday one and 100% at week one,compared to 97% at day one andweek one in the FS 60kHz group.Ninety-four percent and 92% ofpatients reached 20/16 on day oneand week one, respectively, in theiFS group, while 82% were 20/16in the FS 60kHz group. In the iFSgroup, 16% achieved 20/10 at dayone and 19% at week one, com-pared to 8% at day one and weekone in the FS 60kHz group.

CustomizationOne of the major benefits of the5th generation femtosecond laseris that it allows surgeons to cus-tomize the architecture of the flapby either adjusting the side-cutangle (as steep as 150 degrees tomake it a true inverted side cut)and/or by creating an ellipticalflap. The benefits of inverted side-cut architecture on flap stabilitywere reported in November 2008by Michael Knorz, M.D., FreeVisLASIK Center, Mannheim,

“ Advancementswith the newiFS, includingthe invertedside-cut archi-tecture andellipticalflap-makingcapabilities,bring LASIK tothe next level.”

David J. Tanzer, M.D.

Germany. This increased flap sta-bility is an especially significantadvantage for our particularpatient population of militaryindividuals, including special oper-ations personnel, aviators, andother naval staff. Currently, we usethe default setting for myopia of140 degrees. At this angle, we cre-ate an 8.95-mm flap as measuredfrom the uppermost portion of thebevel (at the epithelium). If thebevel is increased to 150 degrees,the exposure would be reducedbelow the target 9 mm of corneafor myopes. Thus, the 140-degreeinverted bevel flap has proven tobe an ideal setting for us. Forhyperopes and mixed astigmatismtreatments, I target a 9.15-mmexposure with a 120-degree invert-ed bevel.

In addition to the overall ben-efit of the inverted side-cut archi-tecture, surgeons also have theability to create an elliptical flap.This allows for a reduction in thesize of the flap in the area perpen-dicular to the hinge, thereby spar-ing some peripheral cornea andresulting in a stronger cornealstructure than was previously pos-sible following LASIK.

I look forward to reportingadditional patient data and resultswith the iFS in the near future.

Dr. Tanzer is a captain in the U.S. NavyMedical Corps and director of the U.S. NavyRefractive Surgery Program. Dr. Tanzer canbe reached at david.tanzer@med.navy.mil.

Figure 1: At day one post-op, 82% of patients achieved 20/20 with the FS 60, compared with97% with the iFS

Figure 2: At week one, 92% of patients achieved 20/16 or better with the iFS, compared to82% with the FS 60

20/20 uncorrected visual acuity at 1 day

Uncorrected visual acuity

6 Premium Clinical Options for Cataract & Refractive Surgery

Early results suggest that combination of technologiesprovides best possible laser vision refraction outcomes

Multi-site iLASIK study launched

by William B. Trattler, M.D.

Over the last decade, therehave been significantadvances in laser visioncorrection technologythat provide improved

visual outcomes for our LASIKpatients. There are many excellentlaser systems and modern flap-cre-ating devices that are currentlyavailable. At my center, we rou-tinely use the combination ofCustomVue treatments on theVISX S4IR laser and the Intralasefemtosecond laser, termed iLASIK(Abbott Medical Optics, AMO,Santa Ana, Calif.). Since havingiLASIK available in our practice, Ihave been surprised to see anincreased number of patients with20/15 or better vision. We havenoted that switching to theIntraLase has dramatically reducedflap-related complications as well.

In order to quantify thatimpression, I have helped set up aprospective multi-center study toassess outcomes and patient satis-faction with iLASIK across adiverse range of practices and sur-geons. More than 10 sites are par-ticipating; each will enroll 20 to25 typical myopic subjects, for anexpected total of more than 400eyes in the study.

Subjects must be at least 21years old, with BSCVA of 20/20 orbetter in both eyes. They musthave pre-op manifest refractiveerror between –0.50 D and –6.00D, with a cylinder component upto –3.00 D, and a maximum mani-fest spherical equivalent of –6.00D. Both eyes must demonstraterefractive stability.

Patients with ocular pathology,prior ocular surgery, systemic con-ditions that affect wound healing,or a monovision target will beexcluded from the study.

In addition to visual acuitymeasures, we are also trackingquality-of-vision changes with pre-and post-op WaveScan aberrome-try and contrast sensitivity testing.Early results suggest that this maybe where we see the biggest gainsfrom iLASIK.

At one site, Lackland Air ForceBase in San Antonio, Texas,Charles Reilly, M.D., consultantto the Air Force Surgeon Generalfor Refractive Surgery, has alreadycompleted enrollment for thisstudy. Analysis of his one-monthresults, conducted at a centralstudy center, revealed that hispatients not only achieved excel-lent mean uncorrected visual acu-ity of 20/16 but also experienced asignificant improvement in their

low-contrast visual acuity, from20/35 best-corrected pre-op to20/29 uncorrected post-op.

Preliminary results from theentire group are expected soon,with full three-month results avail-able before the end of the year.

Combining forcesI have been performing customablation for many years now. Onthe Visx platform, our patientsobtain superior results with cus-tom ablations compared to con-ventional treatments. Customablations not only address higher-order aberrations but also ensurethat the treatment is registered tofixed features on the iris. Thisallows the ablation to be adjustedto compensate for pupil centroidshift and cyclorotation.

However, even custom abla-tions with iris registration can behampered by quality-of-visionissues due to the LASIK flap.Several recent studies from differ-ent investigators have shown thatthin flaps made with the IntraLasefemtosecond laser provide patientswith the same visual resultsobtained with surface ablation butwith much faster visual recovery1,2.

Steve Schallhorn, M.D., glob-al medical director of OpticalExpress, compared conventionalLASIK with metal microkeratomeflaps to custom LASIK with fem-tosecond laser flaps. There weresignificant differences in bothachievement of 20/20 acuity andin night driving simulations. Thepatients who had wavefront-guid-ed surgery with femtosecond flapssaw improvements in their abilityto detect and identify road hazardscompared to pre-op, while about

40% of the conventional patientssaw significant losses on thismeasure compared to pre-op(Figure 1)3.

The end result of a thin fem-tosecond flap is a reduced risk ofectasia, less reduction in cornealsensation and therefore less dryeye, and better quality of vision ina shorter period of time.

The next generation femtosec-ond laser, the iFS (AMO), mayhelp by continuing the enhance-ments in results seen with the 60kHZ Intralase. It is faster andallows more customization of theflap, as well as a beveled flap edgethat may promote even betteradhesion of the flap and improvedcorneal strength over time4.

Dr. Trattler is director of cornea at the Centerfor Excellence in Eye Care, Miami. Contacthim at 305-598-2020 or wtrattler@earthlink.net.

References1. Durrie DS, Slade SG, Marshall J.

Wavefront-guided excimer laser ablationusing photorefractive keratectomy and sub-Bowman’s keratomileusis: a contralateraleye study. J Refract Surg. 2008; 24:S77 –S84.

2. Schallhorn S. U.S. Naval Study: wavefront-guided PRK versus wavefront-guidedLASIK. Paper presented at: The XXIIICongress of the ESCRS; September 13,2005; Lisbon, Portugal.

3. Steve C. Schallhorn, MD, David J. Tanzer,MD, Sandor E. Kaupp, MS, Mitch Brown,OD, Stephanie E. Malady, BS; Comparisonof Night Driving Performance afterWavefront-Guided and Conventional LASIKfor Moderate Myopia; Ophthalmology(accepted, awaiting final publications date).

4. Knorz MC, Vossmerbaeumer U.Comparison of flap adhesion strengthusing the Amadeus microkeratome and theIntraLase iFS femtosecond laser in rabbits.J Refract Surg. 2008 Nov;24(9):875-8.

“ Analysis ofthe one-monthresults revealedthat patients notonly achievedexcellent meanuncorrectedvisual acuity of20/16 but alsoexperienced asignificantimprovement intheir low-contrastvisual acuity.”

William B. Trattler, M.D.

Figure 1: Wavefront-guided ablations were shown on average to improve night drivingsimulation performance

Source: Steve Schallhorn, M.D.

Treating dry eye aggressively can boostpatient satisfaction and outcomes

Tears for post-LASIK dry eye

by Marguerite B. McDonald, M.D.

Like any other form of dryeye, there is often a discon-nect between the signs andsymptoms of post-LASIKdry eye. Some patients

complain bitterly of discomfortand fluctuating vision, yet thedoctor doesn’t see any significantclinical signs at the slit lamp.Treating these patients, even inthe absence of clear clinical signs,can entirely change their apprecia-tion of the surgical outcome andreduce the need for enhancement.

Palliative therapy with a high-quality, long-lasting tear like BlinkTears (Abbott Medical Optics,AMO, Santa Ana, Calif.) remainsan important part of the prepara-tion for LASIK, as well as a key topost-op success. The unique visco-adaptive formulation of BlinkTears combined with its distinctivemechanism of action ensures thatthe lubricant spreads out quicklyon the eye, stabilizing the tearfilm and providing a smooth opti-cal surface. This smooth surface isimportant in reducing fluctuationsin vision as epithelial irregularitiesheal after surgery.

Blink Tears is preserved withOcuPure, a gentle dissipating in-eye, non-BAK preservative, so I amless concerned about corneal toxi-city and more comfortable movingfrom unit-dose unpreserved tearsto Blink Tears after four weeks,rather than insisting that patientsuse the more expensive non-pre-served tears for a full threemonths, as I once did.

Blink Tears vs. Systanedrops post-LASIKA number of studies are currentlyunderway to compare Blink Tearsto other tears commonly used inthe refractive surgery setting.

Christopher Starr, M.D., WeillCornell Eye Associates, New York,assembled an impressive group ofinvestigators, including StephenColeman, M.D., Coleman Vision,Albuquerque, N.M., John Stein,M.D., Ophthalmic Consultants ofConnecticut, Fairfield, Conn.,Damon Pettinelli, M.D., BaltimoreEye Physicians, Baltimore, Md.,Marc Bloomenstein, O.D., SchwartzLaser Eye Center, Scottsdale, Ariz.,and myself, to evaluate and com-pare Blink Tears versus Systanedrops (Alcon, Fort Worth, Texas) inpost-LASIK patients with dry eyesymptoms. One hundred patientsscheduled to undergo bilateralmyopic LASIK were randomized toeither group. The preliminaryresults show that treating the signs

“ It improvedcomfort andvision with lessblur than otherdrops, and alsosignificantlyreduced cornealstaining andincreased tearretention onthe ocularsurface.”

Marguerite B. McDonald, M.D.

and symptoms of dry eye post-LASIK with artificial tears improvesvisual outcomes. The researchdemonstrates that Blink Tears sig-nificantly reduced higher-orderRMS error compared to Systanedrops, optimizing visual outcomes.It improved comfort and visionwith less blur than other drops,and also significantly reducedcorneal staining and increased tearretention on the ocular surface.

The results correlate withanother study I recently complet-ed with my colleagues EricDonnenfeld, M.D., OphthalmicConsultants of Long Island,Lynbrook, N.Y., and StephenKlyce, Ph.D., professor of ophthal-mology and anatomy, LouisianaState University Eye Center, NewOrleans, evaluating higher-orderaberrations after instillation ofartificial tears. Early results from

this study indicate that Blink Tearsreduces higher-order aberrationscompared to Systane drops. Withuniform coating and fewer imper-fections across the ocular surface,the Blink Tears group had betterSnellen visual acuity. Most impor-tantly, patients felt their quality ofvision was improved.

With an aggressive regimen fortreating dry eye symptoms bothbefore and after surgery with artifi-cial tears and other therapies, wecan avoid or reduce post-LASIKdry eye and help our refractivesurgery patients achieve the bestpossible outcomes.

Dr. McDonald is a clinical professor of oph-thalmology at New York University School ofMedicine, New York. She is in private practicewith Ophthalmic Consultants of Long Islandin Lynbrook, N.Y. Contact her at 516-593-7778 or margueritemcdmd@aol.com.

Ocular Surface Management 7

Figure 2: Significant inferior superficial punctate keratitis in a patient complaining ofburning eyes

Source: Paul Karpecki, OD

Figure 1: Lissamine green dye reveals considerable corneal staining in this post-LASIK eyeSource: Paul Karpecki, OD

8 Premium Clinical Options for Cataract & Refractive Surgery

We have the advanced technology to provide today’s cataractpatients with the best possible refractive outcomes

Cataract patients: refractive goals

by Eric D. Donnenfeld, M.D.

The common denominatorin all of the major revolu-tions in anterior segmentsurgery, from intraocularlenses to phacoemulsifica-

tion to LASIK, has been more rapidreturn of improved uncorrectedvisual acuity. Presbyopic IOLs offerthe same promise—and demandthe same kind of paradigm shiftfrom anterior segment surgeons.

In order to give our IOLpatients the comfortable experi-ence, nearly immediate visualrehabilitation, and excellentuncorrected vision they expect, wehave to accept that cataract sur-gery has become refractive surgery.

Refractive IOLsOf course, the choice with perhapsthe greatest refractive consequencefor the patient is the IOL itself. Myfirst question for any prospectivecataract patient is whether he orshe minds wearing glasses forreading.

For those who are interested inspectacle-free near vision, we haveseveral options. Monovision, ofcourse, is a time-tested approachthat has provided good results formany patients. However, it takesaway stereopsis, reduces thepatient’s depth perception andbinocular contrast sensitivity, andmay increase glare and halo.

Today’s accommodative IOLsprovide good distance visual acu-ity but a limited and extremelyvariable degree of accommoda-tion, and therefore cannot pro-vide a full range of vision formost presbyopes. In my experi-ence, patients with presbyopicIOLs implanted in one eye whoare not fully satisfied almostalways desire better near (not dis-tance) vision. In the CustomMatch trial, for example, only 1 in100 subjects said they wanted bet-ter distance vision after the firstIOL implant.

My lens of choice for patientswho want spectacle independenceis an aspheric multifocal IOL. Thisoption provides by far the bestrange of near vision. In clinicaltrials of the Tecnis Multifocal(Abbott Medical Optics, AMO,Santa Ana, Calif.), for example,93% of subjects achieved simulta-neous 20/25 or better at distanceand 20/32 (J2-) or better at near,with very high rates of spectacleindependence for common dailytasks (Figure 1).

Customizing lens choiceBefore recommending a presby-

“ Surgeons whomay have triedand given up onimplantingpresbyopic lens-es in the pastwould be wellserved to try thelatest-generationlenses becausethe optics are farsuperior to whatwas availableeven twoyears ago.”

Eric D. Donnenfeld, M.D.

opic lens, find out more about thepatient’s vocation, activities, andvisual demands, as well as toler-ance for glare and halo. In therecent Tecnis Multifocal clinicaltrial, only a small percentage ofsubjects noticed any glare or halo,so one can reassure patients thatthe chance of experiencing thesevisual symptoms is not high. Ifind that most patients who desirespectacle independence and arewilling to pay for a premium lensare typically willing to accept thepossibility of some visual symp-toms to achieve their goal.

Pupil size is also an importantconsideration in IOL selection.The Tecnis Multifocal has a full6.0-mm diffractive lens that isless dependent on pupil size foreither near or distance vision.

The newest generation ofaspheric multifocal IOLs, includ-ing the Tecnis Multifocal and theAcrySof ReStor +3.0 (Alcon, FortWorth, Texas), offers a broaderrange of vision than accommodat-ing IOLs and provides higher-qual-

ity distance vision compared toprevious multifocal generations.

Surgeons who may have triedand given up on implantingpresbyopic lenses in the pastwould be well served to try thelatest-generation lenses becausethe optics are far superior towhat was available even twoyears ago.

It is time for ophthalmologiststo take a good look at whatpatients really want, which isquality distance vision but also theability to read well and be lessdependent on glasses for most oftheir daily activities. This demandis rapidly turning cataract surgeryinto refractive surgery.

Fortunately, new techniquesand technologies that improveoutcomes allow us to deliver the“wow” factor our patients want.

Dr. Donnenfeld is in private practice withOphthalmic Consultants of Long Island, N.Y.Contact him at 516-766-2519 oreddoph@aol.com.

Figure 1: The vast majority of subjects reported being able to function comfortably withoutglasses at all distances

Figure 2: Pupil independence is especially important in low light situations, particularly fornear vision

Innovations in ultrasound delivery, fluidics, and viscoelasticscombine to make phacoemulsification safer than ever before

Phaco safety

by Roger F. Steinert, M.D.

On parallel fronts, pha-coemulsification surgeryhas been getting safer andsafer. In terms of ultra-sound energy, there is

ongoing refinement in two areas.The first is the minimization ofthe energy delivered to the eyethrough improved computer con-trol and more effective micropuls-ing. This began years ago withcold phaco, and the advances inpower modulation have continuedsince, nearly eliminating the riskof wound burn and making phacosurgery much gentler for the eye.

Today we even have advancedpulse shaping that can deliver aninitial power surge to help drivethe needle into the nucleus, thenmodify the wave form back tonormal levels for the rest of thatindividual pulse.

The other innovation in phacopower is the introduction of non-longitudinal modes such as tor-sional and transversal phaco. Bothof these modes add lateral move-ment to the straight forward-and-back motion of the phaco tip, pro-viding better followability and, insome cases, reducing energyrequirements.

Torsional phaco must be per-formed with a bent needle, whiletransversal phaco, available on theWhiteStar Signature system withELLIPS (Abbott Medical Optics,AMO, Santa Ana, Calif.), can bedone with either a bent or straightneedle. ELLIPS is a good option forthe nearly two-thirds of surgeonswho prefer a straight needle.

Getting with the flowOn a routine basis, it is this fol-lowability that the surgeon noticesand most appreciates. As a sur-geon, my goal is for every nuclearparticle to be easily engaged bythe phaco tip and remain adheredto the tip until fully emulsified.This ideal is about more than justconvenience and procedure speed.As soon as one starts moving thetip more posteriorly or peripheral-ly to pursue nuclear fragments, therisk of capsular rupture increases.Staying in the safer, central zoneof the capsule, smoothly drawingthe particles in and keeping themat the tip, dramatically improvessafety.

Secondarily, a faster, smootherprocedure is much gentler to thecorneal endothelium, introducingless BSS and ultrasound energyinto the eye, and causing less trau-ma. We see the payoff of this in

clearer corneas and higher patientsatisfaction on post-op day one.

Customizing your surgeryWhere the WhiteStar Signaturesystem excels is in marrying ultra-sound and fluidics advancementsfor better followability, lower ener-gy, and a more stable anteriorchamber throughout the case. Thesystem has a wide range of pro-grammable settings that can becustomized for each type ofcataract.

The impact of transversalphaco, for example, is seen mostclearly on harder nuclei that wouldotherwise be very challenging toemulsify. However, I use the sameratio of longitudinal and transver-sal phaco for all cases, even as Ivary the energy and pulse rate. Ithink every case benefits from thecombination of longitudinal andlateral phaco tip motion. Anadvantage of the Signature systemis that both modes are used simul-taneously, rather than switchingback and forth as the torsional sys-tem must do.

The Signature also has fusionfluidics, which allow the surgeonto make use of both peristaltic andventuri pumps. This dual-pumpcapability allows me to performsurgery exactly the way I want to,

without giving up the advantagesof either pump style.

I like the peristaltic pump forphacoemulsification because I canuse higher levels of vacuum whileminimizing the risk of surge. Forirrigation and aspiration, my sys-tem is programmed to switch overimmediately to the venturi pump,which allows for very efficient vac-uuming of the capsule withoutany need to change panel settings.This increases the safety of theprocedure because if I happen tograb the capsule, the venturipump is so responsive that vacu-um and flow can be brought downto very low levels quickly. Unlike aperistaltic system, the venturipump doesn’t have to reflux torelease the capsule.

I am comfortable with venturipumps and have always preferredthem for I/A but in the past wasunwilling to give up the peristalticfluidics controls. Now I can haveboth.

Dr. Steinert is professor of ophthalmology,professor of biomedical engineering, directorof the Gavin Herbert Eye Institute, and chairof ophthalmology at the University ofCalifornia-Irvine (UCI). Contact him atsteinert@uci.edu or 949-824-8089.

Refractive Cataract Technologies 9

Figure 1: The Healon family of OVDs offers a range of viscosurgical devices

“ I amcomfortable withventuri pumpsand have alwayspreferred themfor I/A but inthe past wasunwilling to giveup the peristalticfluidics controls.Now I canhave both.”

Roger F. Steinert, M.D.

10 Premium Clinical Options for Cataract & Refractive Surgery

Study shows positive outcomes and highpatient satisfaction for the Tecnis MF

Clinical study outcomes of the Tecnis Multifocal

by Farrell C. Tyson, M.D.

In clinical trials, the recentlyapproved Tecnis MultifocalIOL (Abbott Medical Optics,AMO, Santa Ana, Calif.) pro-vided excellent results, with

enhanced near VA, reading acu-ity/speed, depth of focus, andspectacle independence comparedto the monofocal IOL.

The one-year, non-random-ized, multi-center, masked, bilater-al, parallel-group comparative clin-ical evaluation of 125 multifocaland 125 monofocal subjects evalu-ated the safety and effectiveness ofthe aspheric diffractive TecnisMultifocal ZM900 IOL. Subjectsunderwent bilateral implantationwith the Tecnis Multifocal IOL(TCMF) or the CeeOn 911A mono-focal IOL (CEMN, Abbott MedicalOptics) according to the subject’spreference. The study was laterexpanded to include an additional225 multifocal subjects.

Clinical experienceI was an investigator in the TecnisMF Clinical Trial Expansion. I per-formed 38 bilateral and two uni-lateral implantations with theTecnis MF lens. My patients hadexcellent results, with 87.5%reporting they never wore glassespost-op. They reported excellentpatient satisfaction. Twenty-fourpercent of bilaterally implantedpatients had 20/16 of distanceuncorrected, and 22% were J1+ orbetter uncorrected.

Trial one-year resultsOne-year results are available for118 Tecnis MF subjects and 116CEMN subjects. Mean distanceVAs were statistically and clinicallyequivalent between the twogroups. Mean binocular andmonocular uncorrected and dis-tance-corrected near visual acuitieswere all significantly better for theTCMF than for the CEMN groupby four to five lines of acuity.Eighty-four percent of TCMF sub-jects achieved uncorrected binocu-lar combined VAs of 20/25 dis-tance and 20/32 near, compared to6.2% of the CEMN subjects.

The TCMF group had excellentdepth of focus, maintaining amean of 20/40 or better for far,intermediate, and near distances.Although mean contrast sensitivi-ty scores were lower for the TCMFcompared to the CEMN group,results were not considered clini-cally significant. Halos and nightglare were more common in theTCMF group. Both reading acuityand speed were significantly better

“My patientshad excellentresults, with87.5% reportingthey never woreglasses post-op.”

Farrell Tyson, M.D.

for the TCMF than the CEMNgroup. Furthermore, 84.8% of theTCMF group achieved completespectacle independence comparedto only 5.2% of the CEMN group.In addition, 96.4% of the TecnisMF patients indicated that theyfunctioned comfortably at nearwithout glasses, compared to30.4% of the CEMN group.

We concluded that a key rea-son for subjects choosing a multi-focal over a monofocal IOL is thedesire to be spectacle-free for read-ing. With best distance correctionin place, the TCMF group per-formed significantly better onboth reading acuity and readingspeed tests compared to the CEMNgroup.

SummaryThe Tecnis MF IOL providespatients with significantlyimproved near vision without sig-nificant loss of distance visualfunction compared to a monofocalIOL. Although a slight decrease in

contrast sensitivity and anincrease in halos and night glarewere noted in this trial with theTecnis MF IOL, subject satisfactionwas very high for the lens. Thiswas likely a result of improvedreading ability, the low incidenceof spectacle wear, and the largerange of depth of focus providedby the aspheric Tecnis MF IOL.

Overall, my clinical experiencewith this trial has convinced methat bilateral implantation withthe Tecnis MF is the way to go.With the bilateral implantation, Ihave found that the patient’sintermediate vision is just as goodas or better than a mix-and-matchimplantation with another type oflens. This lens provides excellentvisual outcomes for patients, whoare especially happy that they areno longer dependent on theirglasses.

Dr. Tyson is the medical director of the CapeCoral Eye Center, Fla. Contact him at 239-542-2020 or email him at Farrell.Tyson@capecoraleyecenter.com.

Figure 1: The Tecnis Multifocal IOL

The lens provides improvedPCO-protection

Two-year data on the 1-piece Tecnis

by Donald R. Nixon, M.D.

Another complimentarydesign feature is a step-down orposterior angulation of the opticsrelative to the haptics. This pro-vides posterior compression ofthe posterior optic onto the ante-rior surface of the posterior cap-sule to further enhance IOL cen-tration and stabilization. Theunique haptic-optic geometry wasdesigned to reduce the mass inthis area to further promote thesealing of the posterior capsule inthat particular area.

Studies have also shown thatthe Tecnis 1-piece has the advan-tages of improvement in function-al vision as evaluated in the simu-lated driving test. Because the lenshas a second-generation hydro-phobic acrylic material, it is alsoglistening free (Figure 1).

Recently, it has becomeknown that this lens has one ofthe highest ABBE numbers, whichmeans it has the least amount ofchromatic aberration. In thefuture, I think we will see that theeffectiveness of lowering chromat-ic aberration may be of equally, ifnot greater, importance than itseffect in terms of neutralizingspherical aberration.

Recent findingsIn a recent study we set out todetermine in vivo if these designfeatures enhanced the performanceof the lens. This evaluation of a

head-to-head comparison in vivoshowed superiority of the Tecnis 1-piece design over the AcrySof. Ithad better optical performance andan improved ability to resist lensepithelial cell migration.

We followed a group of 14patients who were included in theFDA study. They were implantedwith the Tecnis 1-piece lens in thefirst eye in November 2005, andthe AcrySof SA60AT was implantedin the other eye within threemonths. Using high definitionphotography, we evaluated theperformance of the lenses andlooked at issues of posterior lensepithelial cell migration. We foundin this relatively small but repre-sentative group of patients thatthere was a statistically significantgreater incursion of lens epithelialcells with the AcrySof design. Thestudy confirmed that the weaknesswas at the area of the haptic-opticjunction, and the Tecnis 1-piecedesign appeared to have an effec-tive barrier for lens epithelial cellmigration so that it had a statisti-cally significant lower incursion oflens epithelial cells. In addition,the grading of the lens epithelialcell migration and the cellulardensity was much lower with theTecnis 1-piece over the AcrySof.

Dr. Nixon is with the Royal Victoria Hospital,Barrie, Ontario, Canada. Contact him at 705-325-0722 or at trimedeyedoc@rogers.com.

“ The Tecnis1-piece designappeared to havean effectivebarrier for lensepithelial cellmigration so thatit had a statisti-cally significantlower incursionof lens epithelialcells.”

Donald Nixon, M.D.

Refractive Cataract Technologies 11

Figure 1: Tecnis 1-piece is glistening free

Two-year data on theTecnis acrylic 1-piece lens(Abbott Medical Optics,AMO, Santa Ana, Calif.)shows improvement in

optical quality, as well as biome-chanical advantages such asdecreased levels of PCO.

Design advancesThe Tecnis 1-piece acrylichydrophobic IOL was designedbased on a desire in the market-place to have access to aspheric 1-piece IOL technology. From itsinception, this lens incorporated aspherical aberration correction,taking the advantages of theTecnis 3-piece and fusing it intothe advances of the Tecnis 1-pieceplatform to add versatility andchoice for surgeons and theirpatients.

A central component of itsdesign is a 360-degree posterioredge including that portion in thearea of the haptic-optic junction.This feature enhances the inhibi-tion of the lens epithelial cellmigration along the anterior sur-face of the posterior capsule.Studies have shown that lenses,such as the AcrySof SA60AT(Alcon, Fort Worth, Texas), that donot have this trait are much moreprone to early and very predictablePCO development through lensepithelial cell migration.

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