Argus II epiretinal prosthesis system in advanced dry AMD: Safety and feasibility study and preliminary functional sesults at 18 months

Session Details

Session Title: Free Paper Session 3: AMD I

Session Date/Time: Thursday 07/09/2017 | 08:30-10:00

Paper Time: 09:30

Venue: Room 118

First Author: : P.Stanga UK

Co Author(s): :    E. Tsamis   A. Papayannis   A. Jalil   J. Dorn   R. Greenberg   W. McGuire              

Abstract Details

Purpose:

Evaluate the safety and benefit of the Argus® II retinal prosthesis system in late stage atrophic age-related macular degeneration (AMD) (d-AMD) with severely affected central vision.

Setting:

Non-randomised, non-controlled, prospective, single-centre study (Manchester Royal Eye Hospital, Manchester and Manchester Vision Regeneration (MVR) Lab at Manchester Royal Eye Hospital & NIHR/Wellcome Trust Manchester CRF, Central Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom)

Methods:

Five d-AMD patients aged between 73 and 82 years, with logMAR 1.0 (6/60) or worse ETDRS vision in both eyes, subfoveal geographic atrophy (GA) confirmed on ultra-wide field colour and fundus autofluorescence (UWF-FAF) imaging and scotoma within the central 20° visual field confirmed by microperimetry and 60° visual field testing, were included and implanted in the worst eye. Safety of the Argus II system was evaluated by recording and monitoring the number and nature of adverse events (AE). Structural changes were assessed by means of imaging (OCT, UWF imaging) and functional testing (Visual acuity, standard automated perimetry, Landolt C acuity, direction of motion, square localisation) assessed efficacy. Functional vision and quality of life were also assessed using the VFQ-25 questionnaire and the FLORA.

Results:

As of March 20 2017, the follow-up period ranged from 12 to 21 months. Surgical results were reproducible across the 5 patients. The number of Adverse Events (AE) per patient during the reported 18 months period ranged from 1 to 5. The most common AE was the presence of macular oedema under the Argus II system, in all patients, within a month after implementation. Other AE included non-rhegmatogenous retinal detachment, proliferative vitreoretinopathy, exposure of explant, hypotony and endophthalmitis. All AE were successfully resolved using standard approaches. Geographic atrophy was measured pre- and post- implantation. There has been an increase in the area of GA in implanted eyes in all patients. However, the GA area also increased in the fellow eyes suggesting that such an enlargement may be due to natural progression of the disease. All patients showed central visual function elicited by the Argus II over the area of GA. No patient reported confusion with the system ON and both eyes open. Patients reported benefits in recognition of facial characteristics and TV watching.

Conclusions:

We report on the first 18 months of the first successful integration of artificial (central-acquired) and natural (peripheral- residual) vision in humans. Functional measurements have shown the successful stimulation of the retina over the area of GA , even after the resolution of AE, and the recording of patient responses in regions of the visual field where absolute scotomas had been present prior to the implantation. The Argus® II retinal prosthesis system is able to restore some central visual function in advanced d-AMD with severely affected central vision.

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