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Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa ((A16))

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ClinicalTrials.gov Identifier: NCT00279500
Recruitment Status : Completed
First Posted : January 19, 2006
Results First Posted : May 17, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products

Brief 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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: Argus 16 Retinal Stimulation System Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects with a confirmed history of advanced retinal degenerative disease and meeting the inclusion criteria listed will be considered as eligible participants in the study. Subjects who have a condition listed in the exclusion criteria will not be allowed to participate in the study. Eligible subjects with the above diagnoses will be recruited from the Doheny Eye Institute at the University of Southern California. Additionally, new subjects encountered in the clinic who fulfill the inclusion criteria will also be eligible to participate. Upon meeting the entry criteria, all subjects must sign an Informed Consent prior to enrollment in the study. Since the subjects are blind, an individual not associated with this study must read the informed consent to the subject. This person must sign the consent form as a witness to the informed consent process.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects
Actual Study Start Date : February 27, 2002
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014


Arm Intervention/treatment
Experimental: single arm study
Argus 16 Retinal Stimulation System-single arm study.
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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279500


Locations
United States, California
Doheny Eye Institute
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Second Sight Medical Products
Investigators
Principal Investigator: Lisa Olmos, MD Doheny Eye Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Second Sight Medical Products
ClinicalTrials.gov Identifier: NCT00279500     History of Changes
Other Study ID Numbers: CP0002
First Posted: January 19, 2006    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: May 22, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn