The Argus II Retinal Prosthesis: 12-month outcomes from a single-study center.

Purpose: To study the anatomic and functional outcomes of Argus II Retinal Prosthesis System implantation in patients with retinitis pigmentosa.

Design: Interventional case series.

Methods: The study population included 6 patients with visual acuity no better than light perception. After the Argus II Retinal Prosthesis System was implanted, complications and anatomic and functional results were studied. The main outcome measures were mobility, square localization, direction of motion, grating visual acuity, and Goldmann visual field, all of which were assessed. Optical coherence tomography was performed.

Results: Implantation of the Argus II Retinal Prosthesis System was safely performed in all patients. One patient experienced postoperative elevation in intraocular pressure, which was controlled medically. In 1 patient, moderate detachment of the choroid occurred postoperatively, and it resolved spontaneously. One patient withdrew from the study. Wound dehiscence, endophthalmitis or retinal detachment was not observed. All patients were able to locate a bright light on the ceiling and a dark line on the floor after the surgery. Performance in square localization tests improved in 4 patients, and direction of motion improved in 3 patients. One patient achieved grating visual acuity. Goldmann visual field test results improved in all patients.

Conclusions: The patients showed improvement in visual tasks after the surgery, and the device was well tolerated and functional over a 1-year follow-up period. A rigorous patient-selection process is necessary to maximize patient compliance with the rigorous follow-up testing schedule. Both patients and medical staff should be prepared for a lengthy, arduous rehabilitation process.