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

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome X-linked juvenile retinoschisis

U.S. FDA Resources

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

No publications provided by Second Sight Medical Products

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Greenwald SH, Horsager A, Humayun MS, Greenberg RJ, McMahon MJ, Fine I. Brightness as a function of current amplitude in human retinal electrical stimulation. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5017-25. Epub 2009 Jul 15.

Caspi A, Dorn JD, McClure KH, Humayun MS, Greenberg RJ, McMahon MJ. Feasibility study of a retinal prosthesis: spatial vision with a 16-electrode implant. Arch Ophthalmol. 2009 Apr;127(4):398-401.

Horsager A, Greenwald SH, Weiland JD, Humayun MS, Greenberg RJ, McMahon MJ, Boynton GM, Fine I. Predicting visual sensitivity in retinal prosthesis patients. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1483-91. Epub 2008 Dec 20.

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

Additional relevant MeSH terms:

Genetic Diseases, Inborn
Eye Diseases
Retinitis Pigmentosa
Retinitis

Retinal Degeneration
Eye Diseases, Hereditary
Retinal Diseases

ClinicalTrials.gov processed this record on November 22, 2009