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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00279500 |
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Date of registration:
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17/01/2006 |
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Primary sponsor: |
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Public title:
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Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
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Scientific title:
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Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects |
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Date of first enrolment:
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February 2002 |
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Target sample size:
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6 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00279500 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lisa Olmos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Doheny Eye Institute |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa
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Intervention(s)
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Device: Argus 16 Retinal Stimulation System
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Primary Outcome(s)
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Ability to resolve multiple percepts and patterns.
[Time Frame: From 2 weeks post-op until end of device usage]
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Medical and surgical risk as a result of device usage.
[Time Frame: From 2 weeks post-op until end of device usage]
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Optimize effectiveness of stimulus parameters.
[Time Frame: From 2 weeks post-op until end of device usage]
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Subject risk as a result of chronic electrical stimulation.
[Time Frame: From 2 weeks post-op until end of device usage]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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