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

Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

This study is ongoing, but not recruiting participants.

Sponsored by:	Second Sight Medical Products
Information provided by:	Second Sight Medical Products
ClinicalTrials.gov Identifier:	NCT00279500

Purpose

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

Condition	Intervention	Phase
Retinitis Pigmentosa	Device: Argus 16 Retinal Stimulation System	Phase I Phase II

Genetics Home Reference related topics:

Eye Diseases Retinal Disorders

ChemIDplus related topics:

Tretinoin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Second Sight Medical Products:

Primary Outcome Measures:

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.

Estimated Enrollment:	8
Study Start Date:	February 2002
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279500

Locations


United States, California
	Doheny Eye Institute
	Los Angeles, California, United States, 90033

Sponsors and Collaborators

Second Sight Medical Products

Investigators


Principal Investigator:	Mark Humayun, MD PhD	Doheny Eye Institute

More Information

Publications indexed to this study:

de Balthasar C, Patel S, Roy A, Freda R, Greenwald S, Horsager A, Mahadevappa M, Yanai D, McMahon MJ, Humayun MS, Greenberg RJ, Weiland JD, Fine I. Factors affecting perceptual thresholds in epiretinal prostheses. Invest Ophthalmol Vis Sci. 2008 Jun;49(6):2303-14.

Study ID Numbers:	CP0002
First Received:	January 17, 2006
Last Updated:	January 8, 2007
ClinicalTrials.gov Identifier:	NCT00279500
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pigmentary retinopathy

Cone rod dystrophy

Retinitis Pigmentosa

Retinitis

Tretinoin

Retinal Degeneration

Eye Diseases, Hereditary

Retinal Diseases

Retinal degeneration

Additional relevant MeSH terms:

Genetic Diseases, Inborn

Eye Diseases

ClinicalTrials.gov processed this record on July 03, 2008