Abstract
IMPORTANCE: The postoperative retinal changes at the interface between an implant electrode array and the retina and whether these anatomic changes have an association with the patient visual performance are unknown. OBJECTIVE: To report morphologic changes in recipients of an Argus II Retinal Prosthesis. DESIGN, SETTING, AND PARTICIPANTS: This consecutive, noncomparative case series study included a retrospective review of the preoperative and postoperative optical coherence tomography of 33 eyes among 33 individuals who underwent Argus II Retinal Prosthesis System implantation between October 28, 2011, and June 8, 2017, at 2 different centers, by the same surgeon (S.R.). Thirteen patients received an implant at Azienda Ospedaliero Universitaria Pisana, Pisa, Italy, between October 28, 2011, and October 27, 2014, and 20 patients underwent surgery at Azienda Ospedaliera Universitaria Careggi, Florence, Italy, between December 20, 2014, and June 8, 2017. Patients were excluded if they did not reach the 6-month follow-up. MAIN OUTCOMES AND MEASURES: All patients were evaluated before surgery, during the first postoperative day, and at 1, 3, 6, 12, and 24 months (subsequently once a year, except for patient-related adverse events), with a comprehensive ophthalmic examination, retinal fundus photography, spectral-domain optical coherence tomography, and visual function tests to evaluate the stability or improvement of their visual performance. RESULTS: Of the 20 patients included in the analysis, all were of white race/ethnicity, 12 (60%) were male, and the mean (SD) age was 57.4 (11.6) years. Optical coherence tomography revealed the development of a fibrosislike hyperreflective tissue limited at the interface between the array and retina in 10 eyes (50%). In 9 of 10 patients (90%), fibrosis evolved and progressed to retinal schisis. Despite the development of the fibrosis and schisis, there was no deterioration in the patient's visual performance evaluated prospectively with visual function tests (square localization and direction of motion). CONCLUSIONS AND RELEVANCE: Optical coherence tomography may be used to observe the retinal anatomic changes in patients with an Argus II Prothesis. This analysis revealed the development of a fibrosislike hyperreflective tissue limited at the interface between array and retina that progressed to retinal schisis but with no deterioration in the patients' visual performance.