Trial record 9 of 208 for:    "Eye Diseases, Hereditary" OR "Lenz microphthalmia syndrome"

Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products
ClinicalTrials.gov Identifier:
NCT00279500
First received: January 17, 2006
Last updated: December 6, 2013
Last verified: December 2013
  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 1
Phase 2

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:


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 ] [ Designated as safety issue: Yes ]
  • Subject risk as a result of chronic electrical stimulation. [ Time Frame: From 2 weeks post-op until end of device usage ] [ Designated as safety issue: Yes ]
  • Ability to resolve multiple percepts and patterns. [ Time Frame: From 2 weeks post-op until end of device usage ] [ Designated as safety issue: No ]
  • Optimize effectiveness of stimulus parameters. [ Time Frame: From 2 weeks post-op until end of device usage ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2002
Estimated Study Completion Date: December 2014
Estimated 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

  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
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 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: Lisa Olmos, MD 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):

Responsible Party: Second Sight Medical Products
ClinicalTrials.gov Identifier: NCT00279500     History of Changes
Other Study ID Numbers: CP0002
Study First Received: January 17, 2006
Last Updated: December 6, 2013
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 July 23, 2014