N/A
Completed N=6
Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
Source: ClinicalTrials.gov NCT00279500 ↗Enrolled (actual)
6
Serious AEs
66.7%
Results posted
May 2018
Primary outcomePrimary: Number of Adverse Events From 2 Weeks Post-op Until the End of the Study — 34 total number of AEs
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events From 2 Weeks Post-op Until the End of the Study |
34 | — |
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
Data sourced from ClinicalTrials.gov (NCT00279500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.