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Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
This study is ongoing, but not recruiting participants.
Study NCT00279500   Information provided by Second Sight Medical Products
First Received: January 17, 2006   Last Updated: January 8, 2007   History of Changes

January 17, 2006
January 8, 2007
February 2002
 
  • 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.
Same as current
Complete list of historical versions of study NCT00279500 on ClinicalTrials.gov Archive Site
 
 
 
Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects

The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.

 
Phase I, Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Retinitis Pigmentosa
Device: Argus 16 Retinal Stimulation System
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
8
December 2007
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279500
 
CP0002
Second Sight Medical Products
 
Principal Investigator: Mark Humayun, MD PhD Doheny Eye Institute
Second Sight Medical Products
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP