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

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 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 retinitis pigmentosa 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. [ Time Frame: From 2 weeks post-op until end of device usage ] [ Designated as safety issue: Yes ]
Subject risk as a result of chronic electrical stimulation. [ Time Frame: From 2 weeks post-op until end of device usage ] [ Designated as safety issue: Yes ]
Ability to resolve multiple percepts and patterns. [ Time Frame: From 2 weeks post-op until end of device usage ] [ Designated as safety issue: No ]
Optimize effectiveness of stimulus parameters. [ Time Frame: From 2 weeks post-op until end of device usage ] [ Designated as safety issue: No ]

Enrollment:	6
Study Start Date:	February 2002
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: single arm study with fellow eye as the comparator	Device: Argus 16 Retinal Stimulation System

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:

Lisa Olmos, MD

Doheny Eye Institute

More Information

No publications provided by Second Sight Medical Products

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nanduri D, Fine I, Horsager A, Boynton GM, Humayun MS, Greenberg RJ, Weiland JD. Frequency and amplitude modulation have different effects on the percepts elicited by retinal stimulation. Invest Ophthalmol Vis Sci. 2012 Jan 20;53(1):205-14. Print 2012 Jan.

Eng JG, Agrawal RN, Tozer KR, Ross-Cisneros FN, Dagnelie G, Greenberg RJ, Chader GJ, Weiland JD, Rao NA, Sadun AA, Humayun MS. Morphometric analysis of optic nerves and retina from an end-stage retinitis pigmentosa patient with an implanted active epiretinal array. Invest Ophthalmol Vis Sci. 2011 Jun 28;52(7):4610-6. Print 2011 Jun.

Horsager A, Boynton GM, Greenberg RJ, Fine I. Temporal interactions during paired-electrode stimulation in two retinal prosthesis subjects. Invest Ophthalmol Vis Sci. 2011 Feb 1;52(1):549-57. Print 2011.

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.

Responsible Party:	Second Sight Medical Products
ClinicalTrials.gov Identifier:	NCT00279500 History of Changes
Other Study ID Numbers:	CP0002
Study First Received:	January 17, 2006
Last Updated:	August 10, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases

Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 22, 2013