Status:
COMPLETED
Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
Lead Sponsor:
Second Sight Medical Products
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00279500
Start Date
February 27 2002
End Date
December 31 2014
Last Update
April 12 2023
Active Locations (1)
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1
Doheny Eye Institute
Los Angeles, California, United States, 90033