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New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01860092
Recruitment Status : Active, not recruiting
First Posted : May 22, 2013
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products

Brief 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.

Condition or disease
Retinitis Pigmentosa

Detailed 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.


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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
Study Start Date : January 2014
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Group/Cohort
Argus II Retinal Prosthesis
Patients implanted with the Argus II Retinal Prosthesis



Primary Outcome Measures :
  1. Safety subjects have reached 2 years post-implant. [ Time Frame: 5 Years ]
    Adverse event rates with the main safety analysis performed when all visits completed


Secondary Outcome Measures :
  1. Visual function [ Time Frame: 5 Years ]
    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.

  2. Functional Vision [ Time Frame: 5 Years ]
    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.

  3. Device Reliability [ Time Frame: 5 Years ]
    Device reliability will be measured by calculating the rate of implant failure over time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Age 25 years or older; both males and females; with severe to profound retinitis pigmentosa; with bare or no light perception in both eyes or with retinal response to electrical stimulation; with previous history of useful form vision
Criteria

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.

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): NCT01860092


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado, Denver
Denver, Colorado, United States, 80204
United States, Florida
U. of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
University of Miami Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Retina Consultants of Hawaii
'Aiea, Hawaii, United States, 96701
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins, Lions Vision Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
University of Minnesota Department of Ophthalmology
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New York
Stony Brook University
East Setauket, New York, United States, 11733
United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Wills Eye Hospital / Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Second Sight Medical Products
Investigators
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Study Director: Jessy Dorn, PhD Second Sight Medical Products, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Second Sight Medical Products
ClinicalTrials.gov Identifier: NCT01860092     History of Changes
Other Study ID Numbers: PM-02
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn