Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study

Ninel Z Gregori, Natalia F Callaway, Catherine Hoeppner, Alex Yuan, Aleksandra Rachitskaya, William Feuer, Hossein Ameri, J Fernando Arevalo, Albert J Augustin, David G Birch, Gislin Dagnelie, Salvatore Grisanti, Janet L Davis, Paul Hahn, James T Handa, Allen C Ho, Suber S Huang, Mark S Humayun, Raymond Iezzi, K Thiran JayasunderaGregg T Kokame, Byron L Lam, Jennifer I Lim, Naresh Mandava, Sandra R Montezuma, Lisa Olmos de Koo, Peter Szurman, Lejla Vajzovic, Peter Wiedemann, James Weiland, Jiong Yan, David N Zacks


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 languageEnglish
JournalAmerican Journal of Ophthalmology
Pages (from-to)87-99
Number of pages13
Publication statusPublished - 09.2018


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