N/A N=6 Treatment

Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

Retinitis Pigmentosa

Bottom Line

View on ClinicalTrials.gov: NCT00279500 ↗

Enrolled (actual)

Serious AEs

66.7%

Results posted

May 2018

Primary outcome: Primary: Number of Adverse Events From 2 Weeks Post-op Until the End of the Study — 34 total number of AEs

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Argus 16 Retinal Stimulation System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Second Sight Medical Products
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events From 2 Weeks Post-op Until the End of the Study	34	—

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.

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

View full record on ClinicalTrials.gov →

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.