Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study

Ninel Z. Gregori, Natalia F. Callaway, Catherine Hoeppner, Alex Yuan, Aleksandra Rachitskaya, William Feuer, Hossein Ameri, J. Fernando Arevalo, Albert J. Augustin, David G. Birch, Gislin Dagnelie, Salvatore Grisanti, Janet L. Davis, Paul Hahn, James T. Handa, Allen C. Ho, Suber S. Huang, Mark S. Humayun, Raymond Iezzi, K. Thiran JayasunderaGregg T. Kokame, Byron L. Lam, Jennifer I. Lim, Naresh Mandava, Sandra R. Montezuma, Lisa Olmos de Koo, Peter Szurman, Lejla Vajzovic, Peter Wiedemann, James Weiland, Jiong Yan, David N. Zacks

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12 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)87-99
Number of pages13
JournalAmerican journal of ophthalmology
Volume193
DOIs
StatePublished - Sep 2018

Bibliographical note

Funding 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.

Publisher Copyright:
© 2018

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