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OpenTrials
Completed

NCT Number: NCT00279500

Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doheny Eye Institute

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Argus 16 Retinal Stimulation System

Device

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.

Primary outcomes

  1. Number of Adverse Events From 2 Weeks Post-op Until the End of the Study

    Time frame: From 2 weeks post-op until end of device usage, up to 10 years.

    All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.

Sponsors and collaborators

Lead sponsor

Second Sight Medical Products

Industry

Registry information

Official study title

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

Acronym: (A16)

Important dates

Study start
2002
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2006
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.