NCT00407602

Argus® II Retinal Stimulation System Feasibility Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Second Sight Medical Products · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigational Phase of the Study: The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa. Post-Approval Phase of the Study: To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System

Detailed description

During the post-approval phase, subjects will undergo annual eye exams, assessments of medical status and adverse events, and measurement of stimulation thresholds. In addition, at the mutual agreement of the investigator and the subject, subjects will have the option of participating in psychophysical research which could occur as frequently as monthly. Functional tests at 10 years: photographic flash, square localization, direction of motion and grating visual acuity.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DEVICE	Implant of Argus II Retinal Prosthesis	epiretinal implantation of device

Timeline

• Start date: 2006-09-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2006-12-05
• Last updated: 2022-01-20
• Results posted: 2021-12-30

Locations

12 sites across 5 countries: United States, France, Mexico, Switzerland, United Kingdom