Full Text View
Tabular View
No Study Results Posted
Related Studies
Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
This study is ongoing, but not recruiting participants.

First Received on January 17, 2006.   Last Updated on June 6, 2011   History of Changes
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: 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 Help Me Understand Genetics
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.

Enrollment: 6
Study Start Date: February 2002
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  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 ClinicalTrials.gov Identifier (NCT Number):
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: Anne-Marie Ripley/VP Clinical & Regulatory Affairs, Second Sight Medical Products
ClinicalTrials.gov Identifier: NCT00279500     History of Changes
Other Study ID Numbers: CP0002
Study First Received: January 17, 2006
Last Updated: June 6, 2011
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 February 02, 2012



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services