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

Am J Ophthalmol. 2018 Sep:193:87-99. doi: 10.1016/j.ajo.2018.06.012. Epub 2018 Jun 27.


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.

Publication types

  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cohort Studies
  • Electrodes, Implanted*
  • Female
  • Humans
  • Internationality
  • Male
  • Middle Aged
  • Prospective Studies
  • Prosthesis Implantation / methods
  • Retina / pathology*
  • Retinitis Pigmentosa / physiopathology
  • Retinitis Pigmentosa / surgery*
  • Visual Acuity / physiology
  • Visual Prosthesis*

Associated data