Artikel
Argus II® Electronic Epiretinal Prosthesis in Advanced Dry AMD: Safety and Feasibility Study and Preliminary Functional Results (P,B)
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Autoren
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Paulo E. Stanga
- Manchester Royal Eye Hospital, MVR Lab and Univ. Manchester, Manchester, Vereinigtes Königreich
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Assad Jalil
- Manchester Royal Eye Hospital, MVR Lab and Univ. Manchester, Manchester, Vereinigtes Königreich
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Emmanouil Tsamis
- Manchester Royal Eye Hospital, MVR Lab and Univ. Manchester, Manchester, Vereinigtes Königreich
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Alessandro Papayannis
- Manchester Royal Eye Hospital, MVR Lab and Univ. Manchester, Manchester, Vereinigtes Königreich
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Jessy D. Dorn
- Second Sight Medical Products, Inc., Sylmar, USA
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Robert J. Greenberg
- Second Sight Medical Products, Inc., Sylmar, USA
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Will McGuire
- Second Sight Medical Products, Inc., Sylmar, USA
| Veröffentlicht: | 3. Juni 2016 |
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Gliederung
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Purpose: Evaluate the safety and benefit of the Argus II® electronic epiretinal prosthesis in late stage "dry" age-related macular degeneration (AMD) (d-AMD) with severely affected central vision.
Methods: 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 United Kingdom). Four d-AMD patients aged between 69 and 81 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. The positioning of the array of electrodes over the area of GA and the distance between them and the neuroretina was assessed on UWF-FAF and Swept Source-OCT. Patients underwent pre and post-operative visual function testing.
Results: All implants were placed within the area of GA. As of March 25 2016, 4 patients have been implanted and followed-up for a period ranging from 3.6 to 9 months. On the 1st post-operative day, patient #1 presented with a retinal detachment under the cable, which responded to air tamponade. Six weeks after implantation patient #4 underwent successful pars plana vitrectomy surgery with the injection of silicon oil to treat a shallow retinal detachment secondary to PVR. 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. Surgical results were reproducible across the 4 patients. Two patients have reported being able to recognize facial characteristics within their central vision.
Conclusions: We report on the first ever successful integration of artificial (central-acquired) and natural (peripheral- residual) vision in humans. We also report on the first ever implantation of an electronic retinal prosthesis in AMD. The Argus II electronic epiretinal prosthesis seems to be well tolerated and able to restore some central visual function in late stage "dry" AMD.
