Cornea - ARVO

ARVO 2013 Annual Meeting Abstracts by Scientific Section/Group - CorneaMalvern, PA) was performed before surgery and one month after thesame, in order to obtain the postsurgical corneal tissue ablation bysubtraction. All surgeries were performed by different surgeons usingthe same microkeratome (M2 single use microkeratome, Moria Inc.,Doylestown, PA). The corneal ultrasonic pachymetry was takencentrally by the same technician. Measurement was performed oneach eye nine times and mean was reported.Results: Data from 26 patients (52 eyes) who underwent LASIKwere available for the initial analysis. We analyzed a total of 19patients (36 eyes). Seven patients were excluded because they did notcome to follow-up visits and two eyes were excluded because ofsurgical complications. The mean age of the analyzed subjects was25.89 years (range 20-42 years). The mean predicted corneal tissueablation depth was 49.11 μm (standard deviation [SD], 19.60 μm)and the mean postsurgical corneal tissue ablation depth was 61.64 μm(SD, 28.07 μm). The mean preoperative spherical equivalent was -4.07 D (SD, 1.92 D) and the mean postoperative spherical equivalentwas 0.18 D (SD, 0.73 D). We analyzed the variables under study witht test (p< 0.001).Conclusions: The postsurgical corneal tissue ablation depth wasgreater than the predicted corneal tissue ablation depth determined bythe platform used in this study, and it should be considered byrefractive surgeons in patients with thin corneas in order to avoidresidual beds of less than 300 μm.Commercial Relationships: Juan A. Curiel, None; CristinaPacheco-Del-Valle, None; Oscar Baca, None; Alejandro Babayan,None; Regina Velasco, NoneProgram Number: 3129 Poster Board Number: D0064Presentation Time: 8:30 AM - 10:15 AMBilateral Implantation of Hydrogel Corneal Inlays in HyperopicPresbyopesAdam J. Roy 1 , Alan J. Lang 1 , Tonya Porter 1 , Keith Holliday 1 , GuruSharma 1 , Arturo Chayet 2 , Edna Favela 1 , Enrique Barragan 3 , SandraGomez 3 . 1 R & D, ReVision Optics, Inc., Lake Forest, CA; 2 CodetVision Institute, Tijuana, Mexico; 3 Laser Ocular Hidalgo, Monterrey,Mexico.Purpose: To provide hyperopic, presbyopic patients with improvednear, intermediate, and distance vision using bilateral hydrogelcorneal inlays.Methods: Twenty-two hyperopic (mean pre-op spherical equivalent(MRSE): 0.99 D (non-dominant eye) and 0.97 D (dominant eye)[+0.25 to +1.75 D]), presbyopic (mean pre-op reading addrequirement: 1.89 D (both eyes) [+1.50 to +2.25 D]) subjects wereimplanted with 2.0 mm diameter hydrogel corneal inlays (ReVisionOptics, Inc.)* under a femtosecond corneal flap, in the non-dominanteye, followed for 3 to 6 months, and then implanted with a like inlayin the dominant eye. The Optec® 6500 Vision Tester was used torecord visual acuities. Ability to perform everyday tasks (five tasksfor each of three distance ranges) without additional visual aid wasascertained using a questionnaire. The study was performed inconformance with an IRB-approved protocol.Results: The non-dominant (NONDOM) and dominant (DOM) eyesin the same subject responded similarly to the corneal inlay. In botheyes measured separately, uncorrected visual acuity (UCVA) hadimproved significantly at 3 months, by an average of 5 lines of near,3 lines of intermediate, and 1 line of distance vision. Near andintermediate vision improved in 100% of the eyes. 86% of implantedNONDOM eyes and 95% of DOM eyes achieved 20/25 or better nearUCVA compared to 0% preoperatively. 77% of implantedNONDOM eyes and 86% of DOM eyes achieved 20/25 or betterintermediate UCVA compared to 0% preoperatively. Both groupshad an average improvement of 1 line distance UCVA though twosubjects lost one line of distance vision in the NONDOM eye. Theaverage distance UCVA for each eye was 20/21. At 3 months afterthe second inlay, binocularly, 95% of subjects achieved 20/25 orbetter near UCVA and intermediate UCVA, and 100% of subjectsachieved 20/20 or better distance UCVA. There was a significantimprovement in task performance and patient satisfaction withbilateral inlays in comparison to pre-op. At 3 months after the 2ndimplantation, 95% of subjects were satisfied or very satisfied withtheir overall vision.Conclusions: Bilateral implantation of the ReVision Optics cornealinlay is potentially an effective tool to improve near, intermediate,and distance vision in hyperopic presbyopes up to +1.75 D MRSE.*CAUTION: Investigational device. Limited by Federal (UnitedStates) law to investigational use.Commercial Relationships: Adam J. Roy, Revision Optics (E);Alan J. Lang, ReVision Optics (E); Tonya Porter, ReVision Optics(E); Keith Holliday, ReVision Optics (E); Guru Sharma, None;Arturo Chayet, None; Edna Favela, Revision Optics (E); EnriqueBarragan, revision optics (C); Sandra Gomez, Revision Optics (C)Program Number: 3130 Poster Board Number: D0065Presentation Time: 8:30 AM - 10:15 AMNear Functional Range of a Near Center Hydrogel Corneal Inlayin Presbyopic SubjectsAlan J. Lang 1 , Adam J. Roy 1 , Keith Holliday 1 , Tonya Porter 1 , GuruSharma 1 , Arturo Chayet 2 , Edna Favela 1 , Enrique Barragan 3 , SandraGomez 3 . 1 R & D, ReVision Optics, Lake Forest, CA; 2 Codet VisionInstitute, Tijuana, Mexico; 3 Laser Ocular Hidalgo, Monterrey,Mexico.Purpose: Explain with clinical data and ray-trace simulations how anintracorneal inlay provides a functional near range, independent ofage (Add) and improves intermediate VA.Methods: 192 emmetropes / low-hyperopes (MRSE: -0.50 to +1.75D), presbyopic (Add 1.50 to +2.50 D), subjects were implanted witha 2 mm diameter hydrogel corneal inlay (RaindropTM Near VisionInlay, ReVision Optics)*, in the non-dominant eye. The Optec® 6500recorded visual acuities. Everyday task performance (five tasks eachdistance) was ascertained via self-questionnaire. The studies wereeach conducted according to an IRB-approved protocol. Zemaxsimulated letter charts yielded near range for fixed VA levels, as afunction of pupil size and spectacle defocus, using the inlay effectderived from post-pre wavefront difference maps in a finite eyemodel. The inlay effect ranged from -4 D at pupil center, returning tothe unaltered anterior cornea at 4 mm diameter.Results: The mean preop uncorrected near visual acuity (UCNVA) islogMAR 0.51 and by 3 months mean UCNVA is logMAR 0.06(p 6points: p 2levels: p