WHICH PROCEDURE HAS the Most Potential to Grow the Market?

Three surgeons share their opinions.

BY AYLIN KILIÇ, MD; RICHARD L. LINDSTROM, MD; AND VANCE THOMPSON, MD, FACS

presbyopia are made of biocompatible that they have been precisely shaped Allograft inlays materials, but these materials are and sized by an excimer laser. not equivalent to allogenic implants Autologous lenticules obtained hold promise in terms of biocompatibility. We from the SMILE procedure have have experience with an allograft been implanted to treat hyperopia, for presbyopia inlay composed of sterile, allogenic presbyopia, and . In one human corneal tissue that has been study, four emmetropic presbyopic and hyperopia designed to alter the shape of the patients each received a presbyopic correction. anterior surface of the , thereby allogenic refractive lenticule (PEARL) adjusting the point of focus of light inlay in the nondominant .2 The BY AYLIN KILIÇ, MD on the retina. The Allotex TransForm investigators found that patients corneal allograft (Allotex) is fashioned experienced an improvement of by trephining donor corneal tissue and 3 to 5 lines in uncorrected near visual resbyopia affects approximately then slicing buttons along the lamellar acuity and that uncorrected distance 2 billion people worldwide,1 plane to produce corneal blanks of remained 20/20 in the but surgical treatment options a nominal thickness (approximately operated eye and binocularly. They for this condition are limited. 25–40 µm). The corneal blanks are concluded that PEARL was safe and Allograft corneal inlays are one then ablated with a 193-nm industrial efficacious for presbyopic correction. Pof the newest options for presbyopia excimer laser (3D-Micromac) to form However, unlike the allogenic human correction, and they can be used for lenticules of a desired shape and size. corneal tissue of allograft inlays, the hyperopic correction as well. The Allograft lenticules have been autologuous lenticules used in PEARL biggest advantage of the allograft inlay used in the past, for instance in are not from an eye bank. is that it is an additive technology; epikeratophakia, in which the lenticule Endokeratophakia, a procedure because no tissue is removed during sits on top of the cornea, usually in which a myopic SMILE lenticule the implantation procedure, patients sutured in place. One limitation of is implanted into a recipient eye will have the opportunity to undergo epikeratophakia, however, was the to correct hyperopia, has also other advanced procedures that may inaccuracy of measuring and shaping been studied. One year after be developed in the future. Therefore, the tissue. I believe that the potential endokeratophakia in one eye of I believe that allograft corneal inlays to grow the refractive market one patient, the eye’s spherical have the most potential to grow the now lies in the use of human corneal equivalent refraction was reduced by market. tissue as intrastromal implants. In 5.25 D, from 11.25 D preoperatively Synthetic corneal inlays that have addition to their biocompatibility, to 6.00 D at 1 year postoperatively.3 been developed for correction of another advantage of allograft inlays is Mean keratometry increased by 1.81 D,

56 CATARACT & REFRACTIVE SURGERY TODAY EUROPE | SEPTEMBER 2019 DEBATES IN REFRACTIVE SURGERY s

from 41.39 to 43.20 D. In this case, We performed the first clinical study The results of our prospective pilot the implanted lenticule caused the of Allotex TransForm allogenic inlays study were comparable to results from cornea to bulge both anteriorly and for the correction of presbyopia and previously published studies of hydrogel posteriorly, and the result of posterior hyperopia, with all inlays implanted and small-aperture corneal inlays. This, surface changes and epithelial thickness under a standard LASIK flap. Our initial in my mind, suggests that sterile allograft remodeling was an undercorrection clinical results do not provide long-term inlays can be considered as having of hyperopia. data in relation to effectiveness and great potential to grow the refractive safety; however, long-term results of surgery market with applications for our CLINICAL STUDY OF AN up to 10 years with epikeratophakia presbyopic and hyperopic patients. n ALLOGENIC INLAY may provide a good indication of 1. Presbyopia: causes, symptoms, and treatment. https://www.allaboutvision. Because corneal allografts are the survival of allogenic implants.4 com/en-gb/conditions/presbyopia/. Accessed August 20, 2019. 2. Jacob S, Kumar DA, Agarwal A, Agarwal A, Aravind R, Saijimol AI. Prelimi- acellular, the risk of sterile tissue donor Krumeich et al found that the lenticules nary evidence of successful near vision enhancement with a new technique: Presbyopic allogenic refractive lenticule (PEARL) corneal inlay using a SMILE immunogenicity will be reduced. in 27 consecutive patients with lenticule. J Refract Surg. 2017;33(4):224-229. 3. Pradhan KR, Reinstein DZ, Carp GI, Archer TJ, Gobbe M, Gurung R. The procedure is easily reversible by keratoconus (stage 1 or 2) remained Femtosecond laser-assisted keyhole endokeratophakia: correction of hyperopia removing the allograft in a minimally stable during 10 years of follow-up by implantataion of an allogenic lenticule obtained by SMILE from a myopic donor. J Refract Surg. 2013;29(11):772-782. invasive procedure. after epikeratophakia. 4. Krumeich JH, Daniel J, Knülle A. Live-epikeratophakia for keratoconus. J Cataract Refract Surg. 1998;24(4):456-463.

aim to treat one of the four main A breakdown of hot options for the correction of , refractive errors—myopia, presbyopia, , and hyperopia—can presbyopia, astigmatism, and hyperopia. help us to achieve that goal. Let’s look at each individually BY RICHARD L. LINDSTROM, MD to identify which procedure has the most potential to grow the market in refractive surgery. Myopia. In the United States, about 40% of the population has myopia.2 In other parts of the world and in n parallel with the Great Recession refractive surgery between 2018 and certain populations, that percentage in 2008, many refractive surgeons 2023. Market Scope anticipates a can reach the low 90s, as is the case reported a decline in surgical vol- compound annual growth rate of in school-aged children in Asia.3 ume. At that time, the procedure 5.2% and an increase in annual surgi- The most likely drivers of growth that seemed to take the biggest hit cal volume of 1.2 million procedures, in myopic vision correction surgery Iwas LASIK—but then again, it was one from 2.3 million in 2018 to 5.5 million over the next 5 to 10 years are LASIK, of only a few procedures available for in 2023. The report also indicates that PRK, and SMILE. At this time, I don’t the surgical correction of refractive the demand for refractive surgery see anything on the horizon that has error. Since the economy rebounded, grew in the United States, Japan, and the potential to be better than these so has refractive surgery volume in some countries in Western Europe in three procedures. most cases. We continue, however, to 2018, and it forecasts modest growth The existing challenge with myopic hear reports of lower procedure rates in the demand for refractive surgery correction is that we have exhausted from some practitioners. Why is this? procedures in response to technologi- the current pool of candidates. The According to Market Scope’s 2018 cal advances, continuing economic next best candidates for this type Refractive Report,1 better spectacle improvement, and rising rates of of surgery are millennials, and they and contact lens technologies are to myopia in developed nations. Given currently prefer contact lenses as an blame for the dip in the refractive this information, the refractive surgery alternative to glasses. The average age market, along with a shift in patients’ market seems to be doing quite well. of contact lens wearers is 31.4 One visual demands due to their increased reason for the continued uptick in use of digital devices. GROWING THE MARKET contact lens wear by the millennial But good news is on the horizon, It continues to be our job as population is that it costs only about as the report also points to a healthy refractive surgeons to grow the $500 a year to wear contact lenses, increase in the global demand for market. And new developments that which is appealing to a population

SEPTEMBER 2019 | CATARACT & REFRACTIVE SURGERY TODAY EUROPE 57 . https://www.clspectrum.com/ The least commonleast The Contact Lens Spectrum No one procedure has the most the has procedure one No winners, pick to forced were I If Refractive lens exchange with awith exchange lens Refractive Hyperopia. smalla require who patients For 2. Ossala A. Nearly 5 billion people will be nearsighted by 2050. https://www. popsci.com/nearly-5-billion-people-will-be-nearsighted-by-2050/. Accessed July 10, 2019. 3. Park A. Why up to 90% of Asian schoolchildren are nearsighted. http:// healthland.time.com/2012/05/07/why-up-to-90-of-asian-schoolchildren- are-nearsighted/. Accessed July 10, 2019. 4. Morgan PB, Woods CA, Tranoudis IG, et al. International contact lens prescribing in 2012. patients who require a large hyperopiclarge a require who patients treatmentbest the however, correction, exchange. lens refractive likely is CONCLUSION in market the grow to potential and type The surgery. refractive be to error refractive of severity and patient, the of age the treated, comfort surgeon of level the even options. surgical of variety a demand the nominate would I though, of umbrella correction vision laser SMILE) and PRK, (LASIK, procedures astigmatism, myopia, correcting for lens refractive and hyperopia and presbyopia— correcting for exchange patients older that caveat the with with patients and astigmatism with with better do often hyperopia high exchange. lens refractive 1. Global demand for refractive surgery growing after economic rebound in major markets. https://eyewire.news/articles/global-demand-for-refractive- surgery-growing-after-economic-rebound-in-major-markets/. Accessed July 10, 2019. toric IOL can be an attractive option attractive an be can IOL toric someIn patients. astigmatic older for becan exchange lens refractive cases, incisionrelaxing corneal a with paired astigmatism. of degrees high correct to Patientshyperopia. is error refractive correctionseek often most who agesthe between are hyperopia for hyperopicfor Desire 40. and 30 of with coincides frequently correction presbyopia.of onset the PRK, LASIK, correction, hyperopic proceduresthe are again SMILE and thegrow to potential most the with forand hyperopes older For market. issues/2013/january-2013/international-contact-lens-prescribing-in-2012. Accessed July 10, 2019. 5. Black S. Presbyopic options in refractive surgery. COPE 46371-R. http:// www.optometrysmeeting.org/documents/handouts/2016/3100.pdf. Accessed July 10, 2019. 6. Astigmatism. https://www.summiteyekc.com/blog/astigmatism. Accessed July 10, 2019. - As with myopic with As % of Population 41.7 36.5 41.6 48.8 36.3 22.9 43.1 6 The next most next The Astigmatism. Scleral implants such as the VisAbilitythe as such implants Scleral If I had to pick one treatmentone pick to had I If correction of myopia and astigmatism and myopia of correction treatment. same the in combined is and scleral surgery such as laser anteriorlaser as such surgery scleral and Vision ACE (LaserACE, excision ciliary presbyopia,for treatments are Group) andinvasive moderately are both but investigation.under still common refractive error, astigmatism, of 30% about of the in present is population. US the astigmatic in growth correction, driven be primarily will correction LASIK, by and patients younger by the cases, many In SMILE. and PRK, est potential to grow the market, it market, the grow to potential est lensrefractive be would currently presbyopia-correctingwith exchange getcan we if particularly IOLs, trulyof generation next the into mostThe IOLs. accommodating theto function restore to way logical replaceto is lens crystalline human foroptions best the think I and it, and monovision are replacement IOLs. presbyopia-correcting Group)(Refocus System Micro-Insert popular and more advanced thanadvanced more and popular areaAnother generations. previous thechallenges that development of forcorrection vision surgical of growth agents pharmacologic is presbyopia theconstrict to designed are that symptomsthe treat to order in pupil presbyopia.of great the has that presbyopia for 176.6 *2019 Presbyopes *2019 Presbyopes (Millions) 15.1 121.8 20.5 61.4 501.5 300.2 - - | SEPTEMBER 2019

TABLE. THE GLOBAL PRESBYOPIC POPULATION POPULATION GLOBAL PRESBYOPIC TABLE. THE 5 409.6 *2019 Total Populations *2019 Total Populations (Millions) 36.1 333.9 49.3 125.9 1,380.9 1,311.6 The second mostsecond The The challenge once again is thatis again once challenge The We are still in search of a surgical a of search in still are We Presbyopia. Presbyopia. It is also worth mentioning that mentioning worth also is It China India Western Europe *Data courtesy of Market Scope Canada United States South Korea Japan Country safety than the synthetic corneal synthetic the than safety experience, have we which with inlays this in growth some see to expect I surgery. refractive of area are presbyopia for lenses contact Daya, MD, FACP, FACS, FRCS(Ed), FACS, FACP, MD, Daya, first the implanted FRCOphth, lenti Allograft Corneal TransForm find we If June. in world the in cules as well as works technology this that greater offers it that and projected presbyopic (Table). presbyopic broad gain can that procedure market. presbyopic the in traction allogenic the is promising most The to alternative an is which lenticule, M. Sheraz inlays. corneal synthetic atropine. atropine. presbyopia.is error refractive common research,Scope Market to According aboutand population US the of 36.5% ispopulation world’s the of 25% few years. few refrac for therapy pharmaceutical popularity. in growing is errors tive patients for option treatment One low-dose is myopia progressive with that, in general, is underemployed underemployed is general, in that, that With college. from debt in and will millennials that expect I said, surgery refractive consider to start late their enter they as seriously more steady see should we result, a As 30s. next the in surgery myopia in growth CATARACT & REFRACTIVE SURGERY TODAY EUROPE

58 s IN REFRACTIVEDEBATES SURGERY - - n Editorial Board Executive Advisory Board CRST CRST Europe I believe that SMILE in cornealin SMILE that believe I The lens is available as a monofocal.a as available is lens The Financial disclosure: None acknowledged Founder, Vance Thompson Vision, Sioux Falls, Member, [email protected] Financial disclosure: Consultant (Carl Zeiss Associate Professor, Medipol University, İstanbul Member, Financial disclosure: None acknowledged Founder, Minnesota Eye Consultants, Minneapolis Member of the Board of Directors, Unifeyed Vision Adjunct Professor Emeritus, Department of Visiting Professor, Gavin Herbert Eye Institute, [email protected] South Dakota Meditec, RxSight) Partners, Minnesota Ophthalmology, University of Minnesota, Minneapolis University of California, Irvine         precision monovision. In the future,the In monovision. precision willRxLAL the that hoped be to is it ofdepth extended in available become models. multifocal and focus CONCLUSION inLAL the and surgery refractive andstay to here surgeryare lenticular ofworlds the influence greatly will surgery. cataract and refractive procedure to grow refractive surgery refractive grow to procedure vision patients’ compresses it because months, 6 to 4 from journey correction lenticularother with typical is which why:is Here weeks. 5 to 3 to solutions, ofdepth extended and multifocal With typi is laser a with fine-tuning IOLs, focus implan after months 3 performed cally to unusual not is also it and tation, capsulotomylaser Nd:YAG an perform otherthe On surgery. after months 6 to 4 inlocked is currently RxLAL the hand, implantation. after weeks 5 to 3 forcorrected be can eyes both Either readers)need will patient (the distance or one eye can be corrected for distance createto near for other the and n VANCE THOMPSON, MD, FACS n n n n AYLIN KILIÇ, MD n n n RICHARD L. LINDSTROM, MD n n n n n - - In my experience, no lens on Motheron lens no experience, my In In the lenticular space, the Lightthe space, lenticular the In The reason that I select SMILE as theas SMILE select I that reason The In both procedures, centrationprocedures, both In than the RxLAL. I believe the RxLAL hasRxLAL the believe I RxLAL. the than lenticulara as potential greatest the it in patients several years before thebefore years several patients in it andavailability, commercial product’s howby amazed was I on early even doctorsreferring and patients our much becan that IOL an of idea the loved weeks3 eye the inside customized select patients Many surgery. after adjustability,its of because RxLAL the andprecision, and customizability, fastest-growingthe is lens this today practice.our in technology preciseand accurate more is Earth procedure’s small sidecut and easily cen easily and sidecut small procedure’s impactpositive a make treatment tered feelI doctors. referring and patients on needlethe move helped has SMILE that anythan more correction vision laser in procedure. contemporary other LENTICULAR SURGERY isRxSight) (RxLAL; Lens Adjustable in involvement My game-changer. a trialsclinical FDA-monitored US the implantto me allowed RxLAL the of excimer laser ablation can be centeredbe can ablation laser excimer In lifted. been has flap the once perfectly treatmentlaser the that rare is it SMILE, itwhen but, centered, perfectly not is LASIK.to convert to choose we not, is havewe procedures SMILE more The we comfortable more the performed, centration. with become have poten most the with procedure corneal oneis it that is market the grow to tial refractivecorneal exquisite most the of Theperformed. ever have I procedures SMILE candidates are basically the samethe basically are candidates SMILE that, them tell also I candidates. LASIK as surgery,refractive undergoing I were it if SMILE well-centered a have rather I’d LASIK well-centered a than treatment gooda was I as long treatment—as both.for candidate theif even LASIK, In paramount. is centeredbe can’t flap laser femtosecond oranatomy corneal of because perfectly all-importantthe challenges, fit orbital | SEPTEMBER 2019

A tie A tie two between treatments— corneal one and one lenticular.

here are two procedures I thinkI procedures two are here impactgreatest the having as of surgery; refractive modern on otherthe and corneal, is one Thompson Vance lenticular. is The corneal procedure that I believeI that procedure corneal The

BY VANCE THOMPSON, THOMPSON, VANCE BY FACS MD, T CORNEAL SURGERY CORNEAL SURGERY refractivegrow to potential most the has thatpatients my tell I SMILE. is surgery monitored clinical trials and theand trials clinical monitored technologiesthe of releases commercial myso procedure, each in required thewith firsthand have I and colleagues refractivea on have can they impact practice.surgery Vision was involved in the US FDA- US the in involved Visionwas —VANCE THOMPSON, MD, FACS

CATARACT & REFRACTIVE SURGERY TODAY EUROPE

60 DEBATES IN REFRACTIVEDEBATES SURGERY TECHNOLOGY IN OUR TECHNOLOGY IN OUR PRACTICE.” THE FASTEST-GROWING THE FASTEST-GROWING SELECT THE RXLAL ... SELECT THE RXLAL ... AND TODAY THIS LENS IS s “MANY PATIENTS