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Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

This study has been completed.
Information provided by (Responsible Party):
Second Sight Medical Products Identifier:
First received: January 17, 2006
Last updated: April 12, 2016
Last verified: April 2016
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: 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

Resource links provided by NLM:

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


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
  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 identifier: 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
  More Information

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
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 Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn processed this record on September 21, 2017