Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa ((A16))

Second Sight Medical Products

Status

Completed

Conditions

Retinitis Pigmentosa

Treatments

Device: Argus 16 Retinal Stimulation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00279500

CP0002

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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