Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Mar 1;137(3):272-278.
doi: 10.1001/jamaophthalmol.2018.6375.

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

Stanislao Rizzo  1 , Laura Cinelli  1 , Lucia Finocchio  1 , Ruggero Tartaro  1 , Francesca Santoro  1 , Ninel Z Gregori  2
Affiliations

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

Stanislao Rizzo et al. JAMA Ophthalmol. .

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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Fibrosis Evolution and Schisis at Follow-up
For patient 91-105 on optical coherence tomography, fibrosis initially appeared as a thin hyperreflective line that thickened over time, becoming a real hyperreflective fibrotic plaque 12 months after implantation (A) and 24 months after implantation (B). C and D, Images of schisis at the last available follow-ups for patient 91-108 and patient 93-106.
Figure 2.
Figure 2.. Mean Electrode-to-Retina Distance for All 20 Patients
Mean electrode-to-retina distance for each patient was placed in ascending order, and error bars represent data distribution. Of 1200 electrodes (60 electrodes of 20 implants), the distance could be measured for 913 electrodes (76.1%). For the remaining 287 electrodes (23.9%), optical coherence tomography scans did not cover all of the implanted area and this measure could not be assessed.
Figure 3.
Figure 3.. Visual Function Tests Results for 2 Patients
The square localization test reports the mean distance from the target in centimeters (accuracy) for the system on and off, and the direction of motion test reports the observed mean response error (stimulus angle – response angle) with the system on and off.
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Busskamp V, Picaud S, Sahel JA, Roska B. Optogenetic therapy for retinitis pigmentosa. Gene Ther. 2012;19(2):169-175. doi:10.1038/gt.2011.155 - DOI - PubMed
    1. Petrs-Silva H, Linden R. Advances in gene therapy technologies to treat retinitis pigmentosa. Clin Ophthalmol. 2014;8:127-136. - PMC - PubMed
    1. McClements ME, MacLaren RE. Gene therapy for retinal disease. Transl Res. 2013;161(4):241-254. doi:10.1016/j.trsl.2012.12.007 - DOI - PMC - PubMed
    1. Al-Shamekh S, Goldberg JL. Retinal repair with induced pluripotent stem cells. Transl Res. 2014;163(4):377-386. doi:10.1016/j.trsl.2013.11.002 - DOI - PMC - PubMed
    1. Lewis PM, Ackland HM, Lowery AJ, Rosenfeld JV. Restoration of vision in blind individuals using bionic devices: a review with a focus on cortical visual prostheses. Brain Res. 2015;1595:51-73. doi:10.1016/j.brainres.2014.11.020 - DOI - PubMed
-