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Paulo E Stanga, Emmanouil Tsamis, Jessy Dana Dorn, Assad Jalil, Soon Ch'ng, Francesco Stringa, Robert Jay Greenberg, Will McGuire; Argus® II Electronic Epiretinal Prosthesis in Advanced Dry Age-Related Macular Degeneration: Safety and Feasibility Study – 1st Year Functional and Structural Results. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4265.
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© ARVO (1962-2015); The Authors (2016-present)
Evaluate the functional benefit and safety of the Argus® II electronic epiretinal prosthesis in late-stage Dry Age-Related Macular degeneration (d-AMD) with severe loss of central vision due to subfoveal Geographic Atrophy (GA).
Non-randomised, non-controlled, prospective, single-centre study. Five d-AMD patients (aged 69-81 years) with ETDRS logMAR 1.0 or worse visual acuity (ETDRS VA) in both eyes, subfoveal GA and scotoma within the central 20° visual field were implanted in the worst eye. Functional and structural changes were assessed using ETDRS Visual Acuity, FF-81-Screening 60° Humphrey® Visual Field Analyzer (VF) (Zeiss®, Germany), Ultra Wide-Field Colour UWFC and Fundus Auto-Fluorescence (UWF FAF) (California Optos®, UK) and Swept-Source Optical Coherence Tomography (SS OCT) (Atlantis® and Triton Plus® Topcon®, Japan). We here report on changes in the surface area of GA, number of defected VF locations, ETDRS VA and adverse events.
At 12 months post-implantation the number of missed VF locations increased by a median of 35% (Range 25-55%) in the implanted eye. ETDRS acuity and GA surface area in the implanted eye showed no significant change compared to the fellow and non-implanted eye. There were 4 Serious Adverse Events (SAEs) related to the procedure or device: one localised non-rhegmatogenous retinal detachment under the cable, two cases of proliferative vitreoretinopathy (PVR), and one case of hypotony. All SAEs responded to gas injection or vitrectomy surgery with silicon oil. In addition, non-serious and stable Macular Oedema was shown as from approximately 1 month after implantation in all patients. Central visual function was elicited by the Argus® II over the GA area in all patients, before and after resolution of the AEs.
We report on the first ever human beings with residual peripheral vision to be able to experience Artificial Central Visual Function. The Argus® II epiretinal prosthesis can effectively and in a reproducible manner elicit visual function over the area of GA in patients with d-AMD. No patient reported confusion with the system ON and both eyes open. The number and nature of SAEs suggest that modifications in the medication regimen, implantation technique, and/or implant design may be advisable.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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