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Original Investigation
January 3, 2019

Assessment of Postoperative Morphologic Retinal Changes by Optical Coherence Tomography in Recipients of an Electronic Retinal Prosthesis Implant

Author Affiliations
  • 1Azienda Ospedaliera Universitaria Careggi, Dipartimento di Medicina e Chirurgia Traslazionale, University of Florence, Florence, Italy
  • 2Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, Florida
JAMA Ophthalmol. 2019;137(3):272-278. doi:10.1001/jamaophthalmol.2018.6375
Key Points

Question  What are the postoperative changes shown on macular optical coherence tomography after implantation of an electronic retinal prosthesis?

Findings  In this case series study of the preoperative and postoperative optical coherence tomography findings of 33 eyes among 33 retinal prothesis implant recipients, 50% of the analyzed patients developed a fibrosislike hyperreflective tissue limited to the interface between the array and the retina, a significant finding. In most of these cases, the area of fibrosis progressed to retinal schisis without a change noted in visual performance, a result reported as statistically significant.

Meaning  These findings suggest that optical coherence tomography may help to identify retinal anatomic changes after retinal implantation.

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.

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