Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

Second Sight Medical Products6 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinitis Pigmentosa

Interventions

Argus 16 Retinal Stimulation SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Doheny Eye Institute

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of Adverse Events From 2 Weeks Post-op Until the End of the Study

All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.

Time frame: From 2 weeks post-op until end of device usage, up to 10 years.

Data from ClinicalTrials.gov

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