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Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

This study is ongoing, but not recruiting participants.
Information provided by Second Sight Medical Products

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Descriptive Information Fields
Brief Title  Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
Official Title  Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects
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.

Detailed Description
Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  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.
Secondary Outcome Measure 
Condition  Retinitis Pigmentosa
Intervention  Device: Argus 16 Retinal Stimulation System
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  8
Start Date  February 2002
Completion Date December 2007
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00279500
Organization ID CP0002
Secondary IDs ††
Study Sponsor  Second Sight Medical Products
Collaborators ††
Investigators 
Principal Investigator:     Mark Humayun, MD PhD     Doheny Eye Institute    
Information Provided By Second Sight Medical Products
Verification Date January 2007
First Received Date  January 17, 2006
Last Updated Date January 8, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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