Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279500
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):
Second Sight Medical Products

Brief Summary:
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 or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: Argus 16 Retinal Stimulation System Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects
Study Start Date : February 2002
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: single arm study with fellow eye as the comparator Device: Argus 16 Retinal Stimulation System

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279500

United States, California
Doheny Eye Institute
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Second Sight Medical Products
Principal Investigator: Lisa Olmos, MD Doheny Eye Institute

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Second Sight Medical Products Identifier: NCT00279500     History of Changes
Other Study ID Numbers: CP0002
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn