Abstract
PURPOSE: To assess the retinal anatomy and array position in Argus II retinal prosthesis recipients.
DESIGN: Prospective, noncomparative cohort study.
METHODS: Setting: International multicenter study.
PATIENTS: Argus II recipients enrolled in the Post-Market Surveillance Studies.
PROCEDURES: Spectral-domain optical coherence tomography images collected for the Surveillance Studies (NCT01860092 and NCT01490827) were reviewed. Baseline and postoperative macular thickness, electrode-retina distance (gap), optic disc-array overlap, and preretinal membrane presence were recorded at 1, 3, 6, and 12 months.
MAIN OUTCOME MEASURES: Axial retinal thickness and axial gap along the array's long axis (a line between the tack and handle); maximal retinal thickness and maximal gap along a B-scan near the tack, midline, and handle.
RESULTS: Thirty-three patients from 16 surgical sites in the United States and Germany were included. Mean axial retinal thickness increased from month 1 through month 12 at each location, but reached statistical significance only at the array midline (P = .007). The rate of maximal thickness increase was highest near the array midline (slope = 6.02, P = .004), compared to the tack (slope = 3.60, P < .001) or the handle (slope = 1.93, P = .368). The mean axial and maximal gaps decreased over the study period, and the mean maximal gap size decrease was significant at midline (P = .032). Optic disc-array overlap was seen in the minority of patients. Preretinal membranes were common before and after implantation.
CONCLUSIONS: Progressive macular thickening under the array was common and corresponded to decreased electrode-retina gap over time. By month 12, the array was completely apposed to the macula in approximately half of the eyes.
Original language | English |
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Journal | American Journal of Ophthalmology |
Volume | 193 |
Pages (from-to) | 87-99 |
Number of pages | 13 |
ISSN | 0002-9394 |
DOIs | |
Publication status | Published - 09.2018 |