CATARACT & REFRACTIVE SURGERY TODAY EUROPE CATARACT &REFRACTIVE SURGERY improve UNVA, and how the change is tolerated by patients’ improve UNVA, and how the change is tolerated by patients’ after implantation of the Raindrop inlay, how it works to stand the nature of the epithelial reshaping that takes place ABOUT THERAINDROP inlay is combined with LASIK. as ametropic eyes. In ametropic eyes, implantation of the • • • nism of action: distance vision. Each of these devices uses a different mecha opportunity to achieve better UNVA without diminishing providing those patients with clear crystalline lenses the have been introduced to the market with the purpose of recent years several models of intrastromal corneal inlays rection of presbyopia among our patients. To that end, in neal tissue. natural flow of nutrients to be maintained through the cor content as the cornea, and it is porous enough to allow a hydrogel material has the same refractive index and water corneal surfaces. BY BEATRICECOCHENER,MD,P Three surgeonsdebatetheusefulnessoftechnologyforpresbyopiacorrection. INLAYS CORNEAL ON THOUGHTS…YOUR FOR PENNY A My colleagues and I performed a study to better under Each of these inlays can be suitable for emmetropic as well This central rise is referred to as a produces a variation in power from center to periphery. Vision Inlay (ReVision Optics) causes a steepening that By reshaping the central cornea, the Raindrop Near effect, with zones for near and distance vision; and Flexivue Microlens (Presbyia) aims to create a multifocal With its different index of refraction from the cornea, the ate and near vision; provides increased depth of field and improves intermedi The pinhole mechanism of the Kamra inlay (AcuFocus) The Raindrop has no refractive power. Its biocompatible The Raindrop has no refractive power. Its biocompatible 2 This transparent meniscus-shaped hydrogel inlay This transparent meniscus-shaped hydrogel inlay there is increased interest in surgical cor With the aging of the population worldwide, PhD MD, Cochener, Béatrice By VISION IMPROVE UNCORRECTEDNEAR PROFILE CANSIGNIFICANTLY INLAY WITHPROFOCALPOWER 1
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COUNTERPOINT . - - - removable. removable. able corneal inlays for presbyopia correction, the Raindrop is over the patient’s light-constricted pupil. As with all avail at a depth of 30% of central corneal thickness and centered is inserted under a femtosecond laser stromal flap created 16 µm. of approximately 7 µm and midperipheral thickening of response at 3 months, with central epithelial thinning VHF ultrasound showed a doughnut-shaped epithelial occurs in the midperipheral cornea. After this procedure, ablation zone. ing decreased progressively toward the periphery of the ened by approximately 6 µm, and the amount of thicken 6 months postoperative, the central epithelium had thick the central cornea. These investigators found that, by the greatest amount of stromal ablation takes place in high frequency (VHF) ultrasound. remodeling after myopic and hyperopic LASIK using very EPITHELIAL REMODELING Figure 1. Epithelial remodeling with the Raindrop inlay. In hyperopic LASIK, the greatest degree of ablation Reinstein and colleagues have studied epithelial 4
h D; ANDWILLIAMF.WILEY, MD 3 3,4 In myopic LASIK, -
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2017 JUNE Analysis of these five eyes showed that, within thewithin that, showed eyes five these of Analysis In other words, the rise in the stroma caused the epithe the caused stroma the in rise the words, other In bio the characterize to was study our of purpose The to0.25 from ranged errors spherical patients’ Preoperatively, showedqualitatively RTVue the on maps epithelial The numerical analysis. We therefore used a custom MatLabcustom a used therefore We analysis. numerical corneathe in surfaces four digitize to program (Mathworks) surfaces,and inlay surface, stromal anterior surface, (anterior thecalculated then program The surface). stromal posterior poste the to normal radii along profile thickness epithelial 3). (Figure surface corneal rior thinningepithelial central inlay, the of diameter 2-mm inlaythe outside and, occurred, µm 16 approximately of lium to flow outward from the region of the inlay, thinninginlay, the of region the from outward flow to lium The peripherally. it thickening and centrally epithelium the toinlay the of effect the extended change this of effect final isheight corneal in change This diameter. its twice about the vision, near and intermediate improved provides what concluded.investigators COLLATERAL EFFECT OF THE INLAY seriessmall a in inlay the by induced changes mechanical OCTFourier-domain RTVue the used We patients. of anteriorstroma the epithelium, the on focus to (Optovue) surfacecorneal anterior in change total the and inlay, the to Raindropthe with implanted emmetropes presbyopic five in betweenvisits postoperative at measured were Patients inlay. implantation. after years 4 and 1 UNVAMean D. -0.50 to 0.00 from ranged cylinder and D 1.00 or0.8 was UDVA mean and decimal), (Snellen 0.2 than less was unsat but vision distance good had all patients these so better, allPostoperatively, glasses. reading without vision near isfactory thatand eye, treated the in UNVA 1.0 achieved patient one but 2).(Figure UNVA 0.8 achieved patient one allowto insufficient was sampling but thinning, of regions Figure 3. Analysis of endothelial changes. endothelial of Analysis 3. Figure - - - In 5 The inlay itself is 34 µm thick at its center, tapering towardtapering center, its at thick µm 34 is itself inlay The Lang and colleagues subsequently measured changes measured subsequently colleagues and Lang Figure 4. Change in epithelial thickness from preoperativefrom thickness epithelial in Change 4. Figure exam. Figure 2. Refractive effect of Raindrop inlay in five patients. five in inlay Raindrop of effect Refractive 2. Figure
ring in the area surrounding the inlay (Figure 1).(Figure inlay the surrounding area the in ring change, the epithelium remodeled over a zone approximate zone a over remodeled epithelium the change, approximatelyof thinning with inlay, the of size the twice ly occur thickening and inlay central the over occurring µm 18 inlay displaced the overlying stroma, and this was reflectedwas this and stroma, overlying the displaced inlay basi was that layer Bowman the of shape the in change a in shapestromal the to response In inlay. the of shape the cally epithelial thinning. Based on these two measurements, they measurements, two these on Based thinning. epithelial change. stromal calculated theof volume the that found investigators The edges. the 30 emmetropic presbyopes implanted with the inlay, they inlay, the with implanted presbyopes emmetropic 30 to changes characterize to measurements wavefront used measure to OCT Fourier-domain and surface corneal the to the anterior stroma and epithelium induced by induced epithelium and stroma anterior the to inlay. meniscus-shaped Raindrop the of implantation Courtesy of Béatrice Cochener, MD, PhD MD, Cochener, Béatrice of Courtesy REFRACTIVE SURGERY 30
POINT | COUNTERPOINT CATARACT & REFRACTIVE SURGERY TODAY EUROPE CATARACT &REFRACTIVE SURGERY -1.25 D myopia with a LASIK procedure. All surgeries -1.25 D myopia with a LASIK procedure. All surgeries the Femto LDV laser (Ziemer). I simultaneously induced implantations, inserting the inlay under a flap created with stenopeic pinhole opening. Around 2010, I performed five disk that is 3.8 mm in diameter and has a 1.6-mm central (Figure 5). This inlay is a 6-μm thick, black, microfenestrated THE KAMRAINLAY whether they should be implemented in my own practice. to carefully evaluate the available presbyopic inlays to decide curiosity in this technology piqued, about 3 years ago I set out sacrifice only a slight amount of distance vision. With my can achieve improved reading ability with corneal inlays and A short time ago, I began hearing from colleagues that patients in Europe for years but only more recently in the United States. address this ubiquitous condition. promises, a corneal approach is another potential avenue to and accommodating IOLs have not fully delivered on their suggesting that the epithelial thinning that occurs after lems in these patients over a follow-up of up to 4 years, CONCLUSION performance of the Raindrop inlay. required to confirm the biotolerance and stability in visual ment in UNVA in the implanted eye. Long-term follow-up is diameter. the inlay’s refractive effect to less than twice the inlay flowing outwardbeyondtheinlaydiameter. FOR YOUR THOUGHTS approximately 3 mm (Figure 4). diameter, epithelial thickening occurred within a diameter of Globally, the most popular corneal inlay is the Kamra Corneal inlays for presbyopia correction have been available We have observed no persistent ocular surface prob This analysis suggests the following: file. surface bytheinlaycreatesprofocalpowerpro That thecentralelevationofanteriorcorneal flap, raisingtheepitheliumandsubsequently cally transmittedthroughtheoverlyingstromal That theRaindropinlay’svolumeisbiomechani In turn, patients experience significant improve true presbyopia reversal is not yet achievable true presbyopia reversal is not yet achievable holy grail of refractive surgery. Given that Presbyopia correction has been deemed the PhD MD, Stodulka, Pavel By PRESBYOPIC INLAYS EXPERIENCE WITH AN UNDERWHELMING
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2017 This extends - - - - dimensional displaywithArtemisveryhigh-frequencydigitalultrasound. 4. ReinsteinDZ,ArcherTJ,GobbeM,SilvermanRH,ColemanDJ.EpithelialthicknessafterhyperopicLASIK:three- 2012;28(3):195-201. after myopicLASIK:three-dimensionaldisplaywithArtemisveryhigh-frequencydigitalultrasound. 3. ReinsteinDZ,ArcherTJ,GobbeM.Changeinepithelialthicknessprofile24hoursandlongitudinallyfor1year Invest OphthalmolVisSci. 2. PinskyPM.Three-dimensionalmodelingofmetabolicspeciestransportinthecorneawithahydrogelintrastromalinlay. ESCRS WinterMeeting;February10-12,2017;Maastricht,Netherlands. 1. CochenerB.Epithelialremodelinginducedbyacornealhydrogelshapechanginginlay.Paperpresentedat:the21st well-selected patients. toolbox as a new option for treatment of presbyopia in Raindrop inlay can now be added our refractive surgical implantation is well tolerated. We hope, therefore, the 2016;57(9):OCT154-161 changing inlay,deducedfromopticalcoherencetomographyandwavefrontmeasurements. 5. LangAJ,HollidayK,ChayetA,Barragán-GarzaE,KathuriaN.Structuralchangesinducedbyacornealshape- at international congresses who had had Kamra inlays at international congresses who had had Kamra inlays or equivalent) of 200 to 250 µm or greater using a 6x6 or less spot/line setting into a femtosecond laser–created corneal pocket with a depth (Editor’s note: AcuFocus now recommends implanting the inlay body reaction, which caused irritation or decreased vision. inlay explantation within 3 years because of interface foreign patients complained of dry eye after surgery. Two required Unfortunately, however, three of the five UNVA. and UDVA were successful, and patients were happy with both their n n Béatrice Cochener, MD, PhD n n Figure 5. The Kamra inlay in situ. In the meantime, I spoke with four refractive surgeons In the meantime, I spoke with four refractive surgeons Brest UniversityHospital,France Zeiss Meditec,Alcon,PhysIOL,Thea,Allergan) Member, Professor andChairmanoftheOphthalmologyDepartment, Financial disclosure: Clinical Investigator (ReVision Optics, Carl Financial disclosure:ClinicalInvestigator(ReVisionOptics,Carl [email protected] CRST Europe 2014;55(5):3093-3106. . EditorialBoard n J RefractSurg . 2010;26(8):555-564. Invest OphthalmolVisSci JRefractSurg.
. Courtesy of Pavel Stodulka, MD, PhD MD, Stodulka, Pavel of Courtesy REFRACTIVE SURGERY 32
POINT | COUNTERPOINT CATARACT & REFRACTIVE SURGERY TODAY EUROPE CATARACT &REFRACTIVE SURGERY for the presbyopic age group. for the presbyopic age group. these patients ended up as hyperopes, which is not optimal time of surgery. This meant that, after inlay explantation, hyperopes or to induce low hyperopia with LASIK at the facturer is 0.50 to 0.75 D, we had either chosen to treat low the optimal preoperative refraction according to the manu Raindrop inlays within 1 year after implantation. Because in some of our patients, and we had to explant two more (Figure 6). Unfortunately, this complication still occurred corneal inlays might be associated with late interface scaring implantation in some patients because I was aware that two patients lost 5 lines of UDVA. and were happy at their early postoperative visits. Over time, ably, and all patients had significant improvements in UNVA Raindrop inlays maintained their postoperative position reli and so I explanted it on postoperative day 2. The other tive day 1. The inlay was repositioned, but it slipped again, the Raindrop inlays had slipped about 0.5 mm by postopera LASIK flap. Raindrop as precisely as possible on the visual axis under a visual axis on the cornea using a surgical pen and placed the to facilitate and verify centration of the inlays. I marked the slit lamp, and we placed the slit lamp in the operating room inlay. We developed a diode central aiming beam for use at a first problem I encountered, however, was centration of the found that surgical manipulation was not challenging. The Even though the Raindrop is a delicate piece of material, I lens trial. Patients had no dry eye symptoms preoperatively. implantation, each patient performed a monovision contact and scotopic pupil size was smaller than 5 mm. Prior to nondominant eye, photopic pupil size was at least 2.5 mm a corneal pocket. cornea. It is designed to be placed under a LASIK flap or into content and a refractive index that is similar to that of the It is made of a hydrogel material with almost 80% water 2 mm in diameter with a central thickness of about 30 a microlens, which was appealing to me. The Raindrop is changing the central corneal curvature with the addition of Raindrop. I chose this inlay because it uses a simple concept, THE RAINDROP refractive inlay. a presbyopic cornea. Thus, I started to look for a smaller might be too large a foreign body to be safely tolerated by surgeons’ experiences, I decided that the Kamra inlay plained about dry eye. From my own results and these already had their Kamra explanted, and the other com result and still has the implant today. However, two had implanted in their own eyes. One was very happy with his I used 0.02% mitomycin C on the stromal bed before I used 0.02% mitomycin C on the stromal bed before Despite verification of the position postoperatively, one of In five patients in whom I implanted the Raindrop in the My next experience with a corneal inlay was with the
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- - - face foreign body reaction. This inlay is 15 Flexivue (Presbia), with the hopes of minimizing the inter Raindrop patients, I decided to try another inlay, the THE FLEXIVUE Figure 6. Fibrosis is seen with this Raindrop inlay. Figure 6. Fibrosis is seen with this Raindrop inlay. Figure 7. The Flexivue inlay in situ. Disappointed again with the clinical results in my Disappointed again with the clinical results in my m thick, about μm thick, about
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POINT | COUNTERPOINT CATARACT & REFRACTIVE SURGERY TODAY EUROPE CATARACT &REFRACTIVE SURGERY conclusions: as outlined in this article, drove me to the following My very limited experience with presbyopic corneal inlays, that patients are offered only the best and safest options. rates into practice must be evaluated continually to ensure Yet I strongly believe that every innovation one incorpo and the first to implant diffractive presbyopic phakic IOLs. being the first surgeon in my country to perform LASIK FOR YOUR THOUGHTS vision. higher-order aberrations, which improved their distance topography-guided surface ablation to decrease lower- and cantly worse than before surgery. Two patients underwent return to preoperative values and, in fact, were signifi explantation, these patients’ UDVA and CDVA did not about half of the Flexivue inlays we had implanted. After interface fibrosis and, within 3 years, forced us to explant also seen in interface foreign body reaction, which caused Unfortunately, similarity to the other corneal inlays was Patients tolerated this kind of mini-monovision quite well. decrease of up to 5 lines of UDVA in implanted eyes. the Raindrop: significant improvement in UNVA but a clinical results were similar to what we had seen with neal pocket without any signs of dislocation. The early https://youtu.be/K-_CfIc8uYg. surgical video of Flexivue implantation can be viewed at but it was achieved without complications in all cases. A introduction into the corneal pocket is quite challenging, a reusable injector for Flexivue insertion. Delicate inlay ets 250 cornea at the slit lamp. Both the Raindrop and the Flexivue are barely visible in the optical power range of 1.50 to 3.50 D in 0.25 D increments. be better tolerated by the cornea. The Flexivue comes in an thinner implant with a central opening should theoretically nutrition to the anterior corneal layer after implantation. A 3.2 mm, and it has a central opening to improve the flow of 50% thinner than the Raindrop. The Flexivue diameter is I have long been keen on refractive surgery innovations, All Flexivue inlays maintained their position in the cor We implanted about 10 Flexivue inlays into corneal pock tions may be required to improve vision. tions may be required to improve vision. Even after explantation, vision does not always return visual acuity that may require explantation; and cant interface foreign body reaction and a decrease in All three of the inlays that I evaluated are manufac Corneal inlays can cause a significant decrease in Corneal inlays are capable of significantly improving UDVA in the implanted eye; UDVA in the implanted eye; UNVA; to preoperative quality, and further surgical interven tured from synthetic materials that can cause signifi m deep (Figure 7). The manufacturer provided μm deep (Figure 7). The manufacturer provided
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JUNE 2017 ------inlay manufactured from a more biocompatible material inlay manufactured from a more biocompatible material decreased visual acuity. One possible solution could be an body interface reaction occurs, the patient can experience correction. As I see it, the main problem is that, if a foreign currently available are not safe solutions for presbyopia tion for presbyopia will be in the lens compensate for presbyopia. However, to me, the final solu pia, and astigmatism and also as a temporary solution to the near future for refractive correction of myopia, hypero made from a biocompatible and biopermeable material in age group brings a high risk of postoperative dry eye. corneal pocket, as LASIK flap creation in the presbyopic Any future biocompatible inlay should be placed inside a corneal inlay, and such an inlay is already in development. FORWARD-THINKING to make the inlay or onlay. disadvantage, however, is the need for human donor tissue tive corneal laser refractive procedures such as LASIK. The the procedure makes the cornea stronger, unlike subtrac error. The theoretical advantage of this approach is that laser is placed in a corneal pocket to correct refractive made from corneal donor tissue and shaped by an excimer with TransForm allogenic tissue (Allotex), an inlay or onlay Mrochen, PhD. With the tissue-addition concept used donor corneal tissue, as has been introduced by Michael above might be with an inlay or onlay manufactured from the implant. that would allow ions and corneal nutrients to pass through n n n n Pavel Stodulka, MD, PhD Therefore, my overall conclusion is that the corneal inlays Therefore, my overall conclusion is that the corneal inlays I am hopeful that we will be able to use corneal inlays I am hopeful that we will be able to use corneal inlays A synthetic collagen might be the best material for a One possible way to overcome the challenges outlined Financialdisclosure:Noneacknowledged and Austria stodulka@lasik.cz Member, Chief EyeSurgeon,CEOofGemini Clinics,CzechRepublic “ correction. safe solutions for presbyopia currently available are not the corneal inlays that are overallMy conclusion is that CRST Europe EditorialBoard —not in the cornea. - - - n REFRACTIVE SURGERY
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Global Advisory Board 2017 JUNE CRST Europe CRST With attention to these three three these to Withattention factors—optimalsurgical the to attention placement, and range, target refractive ocularsurface management— place a canfind inlays corneal modern refractive any in practice. surgical Factor No. 3: Ocular surface management. 3: Factor No. manage postoperative is Kamra the with successto key aperturean of optics The surface. ocular the of ment “ Private practice, Cleveland Eye Clinic, Ohio Private practice, Cleveland Member, [email protected] Financial disclosure: None acknowledged Furthermore, our surgical approach of using a deep tun deep a using of approach surgical our Furthermore, surgicalfactors—proper three these to attention With A steady stream of presbyopic patients with either myopiaeither with patients presbyopic of stream steady A William F. Wiley, MD Wiley, F. William n n n n surface management—corneal inlays can find a place in anyin place a find can inlays management—corneal surface practice. surgical refractive modern or hyperopia seek refractive surgery at our practice. Thepractice. our at surgery refractive seek hyperopia or topatients these for opportunity an presents inlay Kamra Couplingcorrection. distance for goals basic their upgrade opti the achieve to surgeon the allows LASIK with Kamra the extendto and LASIK with D) -1.00 to (-0.75 refraction mal ToKamra. the with vision near achieve to focus of depth the dual-interfacea perform we success, biocompatibility ensure followedinlay, the for pocket deep a creating technique—first ablation. LASIK the for flap shallower a by affectedbe to prone is performance visual that such are inlay aggres we Therefore, abnormalities. surface ocular subtle by andpre- with starts This disease. surface ocular treat sively andpharmaceutical proper and hygiene lid postoperative supplements.dietary nerveof amount the reduce to helps flap, a than rather nel, extended-durationplace also We induced. is that disruption arereplacements and surgery, of time the at plugs punctal course. postoperative the during needed as continued CONCLUSION ocular and range, target refractive optimum placement, is rare to find patients who naturally sit in this target range,target this in sit naturally who patients find to rare is combinedsimultaneous with success had have we thus, and, Kamra.and LASIK ------The To assure optimalassure To PRACTICE By William F. Wiley, MD integralare inlays corneal opinion, my In practice.surgery refractive modern the in achieveto surgery refractive to look Patients SUCCESSFUL INTEGRATION OF OF INTEGRATION SUCCESSFUL A PRIVATE INLAY IN A CORNEAL Kamra inlay has an optimal refractive range to ensureto range refractive optimal an has inlay Kamra baselinea that found have We focus. of depth proper Factor No. 2: Optimal refractive target range. 2: Factor No. optics and biocompatibility, proper surgical place surgical proper biocompatibility, and optics found have We achieved. be must inlay the of ment Factor No. 1: Surgical placement. Surgical placement. 1: Factor No. Depth of placement must be considered in regard to bio to regard in considered be must placement of Depth We have found the small-aperture Kamra inlay to be suc be to inlay Kamra small-aperture the found have We Surgeons in the United States are thankful for the pioneeringthe for thankful are States United the in Surgeons vision from this baseline functioning intermediate vision. It vision. intermediate functioning baseline this from vision refraction of -0.75 to -1.00 D increases visual performancevisual increases D -1.00 to -0.75 of refraction inter good takes optic aperture the Basically, inlay. the with nearand distance the both extends and vision mediate biocompatibility can reduce or eliminate the body’s inflam body’s the eliminate or reduce can biocompatibility of depth a at inlays place We inlay. the to response matory corneal a through implanted are they and µm, 300 to 250 pocket. compatibility. The deeper layers of the cornea have been have cornea the of layers deeper The compatibility. this and material, implanted of tolerant more be to shown In our series of cases to date, we have never had to reposi to had never have we date, to cases of series our In visualthe on placement to this attribute We inlay. an tion guidance.intraoperative and pre- on based axis visualization with on-axis Purkinje light projection. For the For projection. light Purkinje on-axis with visualization Visxthe of light ring the on fixation patient use we latter, Vision).Johnson & (Johnson platform laser excimer IR S4 Star that the inlay must be centered on the visual axis. Thisaxis. visual the on centered be must inlay the that thewith analysis diagnostic preoperative by guided be can intraoperativeproper by and (AcuFocus) HD AcuTarget surface management.surface and a removal rate of less than 2%. To achieve this success,this achieve To 2%. than less of rate removal a and placement,surgical factors: key three on focused have we ocularpostoperative and range, target refractive optimum cessful in our practice. We have implanted more than 175 of175 than more implanted have We practice. our in cessful ratesuccess high a with months 14 past the over inlays these change the nature of the inlay procedure in our practice. our in procedure inlay the of nature the change FACTORS THREE KEY THOUGHTS: FOR YOUR steps our European colleagues undertook to help us all under all us help to undertook colleagues European our steps haveThere inlays. with failure) (and success to keys the stand tohelped have together, taken that, changes of number a been incision lenticule extraction, refractive lens exchange, andexchange, lens refractive extraction, lenticule incision presbyopiaof treatment the for inlays Corneal IOLs. phakic options. of list this complement spectacle independence, and there is a growing number ofnumber growing a is there and independence, spectacle smallPRK, LASIK, including goal, that achieve to options