ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01860092
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : July 23, 2018
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.


Study Type : Observational
Estimated 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.


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


Contacts
Contact: Jessy Dorn, PhD 855-756-3703 patients@2-sight.com

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Nelson Aguilar    323-442-6490    nelson.aguilar@med.usc.edu   
Principal Investigator: Lisa Olmos, MD         
United States, Colorado
University of Colorado, Denver Recruiting
Denver, Colorado, United States, 80204
Contact: Mary Preston    720-848-2035    MARY.PRESTON@UCDENVER.EDU   
Principal Investigator: Naresh Mandava, MD         
United States, Florida
U. of Miami, Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Potyra Rosa    305-202-4731    prosa@med.miami.edu   
Principal Investigator: Byron Lam, MD         
University of Miami Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Byron Lam, MD         
Principal Investigator: Byron Lam, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jiong Yan       jyan2@emory.edu   
Principal Investigator: Jiong Yan, MD         
United States, Hawaii
Retina Consultants of Hawaii Recruiting
'Aiea, Hawaii, United States, 96701
Contact: Sheila Chamian    808-380-8060    sheila@retinahi.com   
Principal Investigator: Gregg Kokame, MD         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Marcia Niec    312-355-3743    mniec@uic.edu   
Principal Investigator: Jennifer Lim, MD         
United States, Maryland
Johns Hopkins, Lions Vision Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Olukemi Adeyemo    443-287-0072    oadeyem2@jhmi.edu   
Principal Investigator: Gislin Dagnelie, PhD         
Tufts Medical Center Recruiting
Boston, Maryland, United States, 02111
Contact: Michelle Liang, MD         
Principal Investigator: Michelle Liang, MD         
United States, Michigan
University of Michigan, Kellogg Eye Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Kari Branham    734-936-8638    haag@med.umich.edu   
Principal Investigator: Thiran Jayasundera, MD FACS         
United States, Minnesota
University of Minnesota Department of Ophthalmology Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Wendy Elasky    612-626-3056    waelasky@umn.edu   
Principal Investigator: Sandra Montezuma, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Rebecca Nielsen    507-284-5833    nielsen.rebecca@mayo.edu   
Principal Investigator: Raymond Iezzi, MD         
United States, New York
Stony Brook University Recruiting
East Setauket, New York, United States, 11733
Contact: Khurram Chaudhary, MD         
Principal Investigator: Khurram Chaudhary, MD         
United States, North Carolina
Duke University Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: LaToya Greene    919-684-9072    latoya.greene@duke.edu   
Principal Investigator: Paul Hahn, MD, PhD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Meghan Marino    216-445-7671    marinom2@ccf.org   
Principal Investigator: Alex Yuan, MD, PhD         
United States, Pennsylvania
Wills Eye Hospital / Mid Atlantic Retina Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jennifer Castaldi    215-928-3092    research@midatlanticretina.com   
Principal Investigator: Allen Ho, MD         
United States, Texas
Retina Foundation of the Southwest Recruiting
Dallas, Texas, United States, 75231
Contact: Kirsten Locke    214-363-3911    kglocke@retinafoundation.org   
Principal Investigator: David Birch, PhD         
Sponsors and Collaborators
Second Sight Medical Products
Investigators
Study Director: Jessy Dorn, PhD Second Sight Medical Products, Inc.

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: July 23, 2018
Last Verified: July 2018

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