Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

— (A16)  

Official title:

Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279500
• Other study ID #: CP0002
• Status: Completed
• Phase: N/A
• Start date: February 27, 2002
• Est. completion date: December 31, 2014

Study information

• Verified date: April 2018
• Source: Second Sight Medical Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.

This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• Argus 16 Retinal Stimulation System
The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.

Locations

Country	Name	City	State
United States	Doheny Eye Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Second Sight Medical Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events From 2 Weeks Post-op Until the End of the Study	All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.	From 2 weeks post-op until end of device usage, up to 10 years.