Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa - Tabular View

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Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

This study is ongoing, but not recruiting participants.
Information provided by Second Sight Medical Products

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

Official Title ^†

Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects

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

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Medical and surgical risk as a result of device usage.
Subject risk as a result of chronic electrical stimulation.
Ability to resolve multiple percepts and patterns.
Optimize effectiveness of stimulus parameters.

Secondary Outcome Measure ^†

Condition ^†

Retinitis Pigmentosa

Intervention ^†

Device: Argus 16 Retinal Stimulation System

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

February 2002

Completion Date

December 2007

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00279500

Organization ID

CP0002

Secondary IDs ^††

Study Sponsor ^†

Second Sight Medical Products

Collaborators ^††

Investigators ^†

Principal Investigator:

Mark Humayun, MD PhD

Doheny Eye Institute

Information Provided By

Second Sight Medical Products

Verification Date

January 2007

First Received Date ^†

January 17, 2006

Last Updated Date

January 8, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.