Purpose: To assess the retinal anatomy and array position in Argus II retinal prosthesis recipients. Design: Prospective, noncomparative cohort study. Methods: SETTING: International multicenter study. PATIENTS: Argus II recipients enrolled in the Post-Market Surveillance Studies. PROCEDURES: Spectral-domain optical coherence tomography images collected for the Surveillance Studies (NCT01860092 and NCT01490827) were reviewed. Baseline and postoperative macular thickness, electrode-retina distance (gap), optic disc–array overlap, and preretinal membrane presence were recorded at 1, 3, 6, and 12 months. MAIN OUTCOME MEASURES: Axial retinal thickness and axial gap along the array's long axis (a line between the tack and handle); maximal retinal thickness and maximal gap along a B-scan near the tack, midline, and handle. Results: Thirty-three patients from 16 surgical sites in the United States and Germany were included. Mean axial retinal thickness increased from month 1 through month 12 at each location, but reached statistical significance only at the array midline (P =.007). The rate of maximal thickness increase was highest near the array midline (slope = 6.02, P =.004), compared to the tack (slope = 3.60, P <.001) or the handle (slope = 1.93, P =.368). The mean axial and maximal gaps decreased over the study period, and the mean maximal gap size decrease was significant at midline (P =.032). Optic disc–array overlap was seen in the minority of patients. Preretinal membranes were common before and after implantation. Conclusions: Progressive macular thickening under the array was common and corresponded to decreased electrode-retina gap over time. By month 12, the array was completely apposed to the macula in approximately half of the eyes.
Bibliographical noteFunding Information:
Funding/Support: Supported by VitreoRetinal Surgery Foundation (Minneapolis, Minnesota) Award (to Natalia Callaway and Ninel Z. Gregori), NIH Center (Bethesda, Maryland) Core Grant P30EY014801 , Research to Prevent Blindness (New York City, New York) Unrestricted Grant, Department of Defense (Washington, DC) (DOD-Grant#W81XWH-09-1-0675). The sponsor or funding organizations had no role in the design or conduct of this research. Second Sight Medical Products, Inc, provided funding for the Post-Market Surveillance Study to individual institutions but did not directly sponsor or influence the current work. Financial Disclosures: Ninel Z. Gregori: Regeneron, Inc (consultant). Alex Yuan: Second Sight Medical Products, Inc (research grant), NIH/NEI K08 EY023608 (unrelated grant). Aleksandra Rachitskaya: Allergan, Carl Zeiss Meditec (consultant). William Feuer: National Eye Institute (grants: U10EY024247 and P30EY014801); Johnson and Johnson (grant); Glaucoma Associates of Texas, Retinal Care LLC, Tissue Tech (consultant). Hossein Ameri: Second Sight (USC grant for clinical trials), Spark Therapeutics (advisory board). J. Fernando Arevalo: Springer SBM LLC (royalties); EyEngineering Inc, Turing Pharmaceuticals LLC, Mallinckrodt (consultant); Dutch Ophthalmic Research Consultants International B.V., Allergan Inc, Bayer (consultant, lecture fees). Albert J. Augustin: Allergan, Alimera (consultant, speakers honoraria, study grants); Novartis, Bayer (study grants); Second Sight Medical Products, Inc (speakers honoraria, study grants). David G. Birch: Nightstar, Inc, AGTC, Nacuity Pharmaceuticals, Acucela, Inc (consultant); Nightstar, Inc, Ionis Pharmaceuticals, Inc, Allergan, AGTC, 4D Molecular Therapeutics, Inc, Second Sight Medical Products, Inc (clinical trial support). Gislin Dagnelie: Second Sight Medical Products (consulting, patents, clinical trial funding); QLT Inc [now Novelion] (consulting, licensing fees); eSight Corp (consulting, equity); grants NIH R01 EY028452, R42 EY025136, R44 EY024498, R44 EY027650, UG3 NS095557 and DoD W81XWH-17-1-0621. Salvatore Grisanti: Alcon, Allergan, Bayer, Humanoptics, Novartis, Pfizer, Roche, Transcend (advisory boards, presentation, studies); Refocus, Thrombogenics (studies). Janet L. Davis: Abbvie, Allergan (consultant). Paul Hahn: Second Sight Medical Products, Inc, Genentech, Inc (consultant). James T. Handa: Bayer Pharmaceuticals, Inc, NIH R01 EY027691, NIH 2R01 EB000526-07, BrightFocus Foundation, Macular Degeneration Foundation, Knights Templar Grant (unrelated grants). Allen C. Ho: Aerie Pharmaceuticals, AsclepiX Therapeutics, Beaver Visitec, BioTime, Kang Hong Biotech, Novo Nordisk, Notal Vision, Tyrogenex (consulting); AGTC, Alcon, Allergan, Genentech, Janssen, Regeneron, Regenix, Second Sight (consulting, grant); Pan Optica (consulting, grant, equity). Suber S. Huang: American Academy of Ophthalmology (consultant/advisor; Chair, AAO Research, Regulatory, Scientific Affairs committee during study); Asia Pacific Association of Ophthalmology, Santen, Spark Therapeutics, Volk (consultant/advisor); Diopsys (consultant/advisor, grant support, lecture fees); i2i Innovative Ideas, Inc (consultant/advisor, equity owner); Lumoptik (consultant, equity owner); NEHEP/NEI/NIH (consultant/advisor; Chair, National Eye Health Education Program); Regenerative Patch Technologies, RegenXBio (consultant/advisor; Chair, DMC); Second Sight (consultant/advisor; Independent Medical Safety Monitor). Mark S. Humayun: 1Co, Inc, oProbe, Reflow, Regenerative Patch Technologies, Replenish, Second Sight Medical Products, Inc (consultant/advisor, equity owner, patents/royalties); Alcon Laboratories Inc (consultant/advisor, lecture fees); Clearside, Allergan (consultant/advisor); Eyemedix (consultant/advisor, equity owner, patent/royalty, grant support); IRIDEX, Duke Eye Center, Johns Hopkins University (patents/royalties); Santen, Inc (consultant/advisor, speaker, honorarium); University of Southern California (employee, patents/royalty); Acucela (consultant/advisor, lecture fees). K. Thiran Jayasundera: NIH funding (K23 EY026985-01); Second Sight Medical Products, Inc, Editas Medicine (consultant). Gregg T. Kokame: Genentech (research support, consultant), Regeneron (research support, consultant, speaker); Bausch and Lomb, Second Sight, Bayer (consultant, speaker); Zeiss, Santen, Allergan, Ophthotech (consultant). Byron L. Lam: AGTC, Astellas, National Eye Institute, NightstaRx, Quark, Sanofi, Second Sight Medical Products, Inc (grant support); Shire (consultant/advisor, grant support); Ionis, Spark (consultant). Jennifer I. Lim: Alcon, Genentech, pSivida, Ophtea, Quark, Kodiak, Santen, Pfizer/Hospira, Regeneron, Lumenis, Alexion, AbbVie, Alimera (consultant); Allergan, Janssen, Ohr, Second Sight, Regeneron, Genentech, Clearside (grants for UIC clinical trials); JAMA Ophthalmology Editorial Board, Vindico, CRC Press (honoraria). Naresh Mandava: Shapetech LLC, Shape Ophthalmics LLC, 2C Tech corporation (founder, equity); Aurea Medical, LLC (founder, consultant, equity); ONL Therapeutics (consultant, equity). Sandra R. Montezuma: Second Sight Medical Products, Inc (consultant); Spark Therapeutics (advisory board). Lisa Olmos de Koo: Alcon Surgical R&D, ScienceBased Health (Scientific Advisory Board Member). Lejla Vajzovic: Novartis, Second Sight Medical Products, Inc, Roche (research grant); Regeneron, Janssen (consultant); Dutch Ophthalmic Research Center (honoraria, consultant). Peter Wiedemann: Bayer, Regeneron, Thrombogenics, Novartis, Allergan (clinical study grants). James Weiland: Platinum Group Coatings, LLC (ownership, consultant); Second Sight Medical Products, Inc (research collaboration). Jiong Yan: funding for MacTel study (NHOR, MacTel phase 2 and 3) from the Lowy Medical Foundation. David N. Zacks: ONL Therapeutics (equity, consulting, royalties); Foundation Fighting Blindness (research grant). The following authors have no financial disclosures: Natalia F. Callaway, Catherine Hoeppner, and Raymond Iezzi Jr. All authors attest that they meet the current ICMJE criteria for authorship.