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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01860092
Other study ID # PM-02
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 2014
Est. completion date March 2020

Study information

Verified date December 2021
Source Second Sight Medical Products
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.


Description:

Safety data will be monitored to ensure continued acceptability of risks to study subjects. The utility (i.e. visual function and functional vision) and reliability of Argus II System will also be evaluated. There is no study hypothesis.


Recruitment information / eligibility

Status Terminated
Enrollment 53
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility Inclusion Criteria: - Are adults, age 25 year or older; - Have severe to profound retinitis pigmentosa; - Bare light or no light perception in both eyes; if the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed; - Have previous history of useful form vision. - Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.) - Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation; - Have consented to the implantation of an Argus II Retinal Prosthesis and subsequently consent to participate in this study; - At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. myocardial infarction, etc.) and Exclusion Criteria: - Ocular diseases or conditions that could prevent Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus); - Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva, axial length <20.5 mm or >26 mm, corneal ulcers, etc.); - Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity, etc.); - Inability to tolerate general anesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery; - Metallic or active implantable device(s) (e.g. cochlear implant) in the head; - Pre-disposition to eye rubbing; - Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including: - cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease, - psychiatric disease including diagnosed forms of depression; - does not speak a principal language associated with the region, and - deafness; - Pregnant or wish to become pregnant during the course of the study; - Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study; - Conditions likely to limit life to less than 1 year from the time of inclusion.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Retina Consultants of Hawaii 'Aiea Hawaii
United States University of Michigan, Kellogg Eye Center Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States Johns Hopkins, Lions Vision Center Baltimore Maryland
United States Tufts Medical Center Boston Massachusetts
United States University of Illinois at Chicago Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Retina Foundation of the Southwest Dallas Texas
United States University of Colorado, Denver Denver Colorado
United States Duke University Eye Center Durham North Carolina
United States Stony Brook University East Setauket New York
United States University of Southern California Los Angeles California
United States U. of Miami, Bascom Palmer Eye Institute Miami Florida
United States University of Miami Bascom Palmer Eye Institute Miami Florida
United States University of Minnesota Department of Ophthalmology Minneapolis Minnesota
United States Wills Eye Hospital / Mid Atlantic Retina Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota

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 Safety subjects have reached 2 years post-implant. Adverse event rates with the main safety analysis performed when all visits completed 5 Years
Secondary Visual function Visual function means how to the eye works (e.g. visual acuity). Visual function will be measured using the following test: Square Localization, Direction of Motion and Grating Visual Acuity (GVA).In addition to these tests, a photographic flash test will be performed with the System OFF only to determine if subjects' native residual vision is bare light perception or no light perception. 5 Years
Secondary Functional Vision Functional vision means how subjects perform in vision-related activities of daily living. Function vision will be assessed using the Functional Low-Vision Observer Rated Assessment (FLORA). A utilization questionnaire will also be administered to track how subjects are using the Argus II System. 5 Years
Secondary Device Reliability Device reliability will be measured by calculating the rate of implant failure over time. 5 Years
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