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:	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: cone-rod dystrophy retinitis pigmentosa

Genetic and Rare Diseases Information Center resources: Retinitis Pigmentosa Cone-rod Dystrophy Cone-rod Dystrophy 2

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 ]
Subject risk as a result of chronic electrical stimulation. [ Time Frame: From 2 weeks post-op until end of device usage ]
Ability to resolve multiple percepts and patterns. [ Time Frame: From 2 weeks post-op until end of device usage ]
Optimize effectiveness of stimulus parameters. [ Time Frame: From 2 weeks post-op until end of device usage ]


Enrollment:	6
Study Start Date:	February 2002
Study Completion Date:	December 2014
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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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. doi: 10.1167/iovs.11-8401.

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. doi: 10.1167/iovs.09-4936.

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. doi: 10.1167/iovs.10-5282. Print 2011 Jan.

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. doi: 10.1167/iovs.08-2897. 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. doi: 10.1001/archophthalmol.2009.20.

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. doi: 10.1167/iovs.08-2595. 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. doi: 10.1167/iovs.07-0696.


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:	April 12, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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 July 18, 2017