Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinitis Pigmentosa
- Sponsor
- Second Sight Medical Products
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Number of Adverse Events From 2 Weeks Post-op Until the End of the Study
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Adverse Events From 2 Weeks Post-op Until the End of the Study
Time Frame: 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.