Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

Not Applicable

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Device: Argus 16 Retinal Stimulation System

• Registration Number: NCT00279500
• Lead Sponsor: Second Sight Medical Products

Brief Summary

The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.

Detailed Description

The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.

This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.

Study Timeline

• Study Start: 2002-02-27
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-19
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Results First Submitted: 2017-06-14
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-16
• Results First Posted: 2018-05-17
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. The fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery.
• History of former useful form vision in worse-seeing eye
• Acceptable ability to describe visual percepts
• Age eighteen (18) or older

Exclusion Criteria

• History of glaucoma
• Optic neuropathy or other confirmed damage to optic nerve or visual cortical damage
• Presence of communicable disease/infection
• Pregnancy
• History of claustrophobia
• Inconsistent flash detection thresholds
• Any other diseases that can effect the function of the retina
• Subjects with a Beck Depression Inventory Interpretation score of >30 and subsequent diagnosis of depression by a psychiatrist.
• Corneal degeneration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm study	Argus 16 Retinal Stimulation System	Argus 16 Retinal Stimulation System-single arm study.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events From 2 Weeks Post-op Until the End of the Study	From 2 weeks post-op until end of device usage, up to 10 years.	All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.

Trial Locations

Locations (1)

Doheny Eye Institute; 🇺🇸 Los Angeles, California, United States