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

NCT ID: NCT01860092

Last Updated: 2021-12-23

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2020-03-31

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.

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.

Conditions

Retinitis Pigmentosa

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Argus II Retinal Prosthesis

Patients implanted with the Argus II Retinal Prosthesis

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Sight Medical Products

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessy Dorn, PhD

Role: STUDY_DIRECTOR

Second Sight Medical Products, Inc.

Locations

University of Southern California

Los Angeles, California, United States

University of Colorado, Denver

Denver, Colorado, United States

U. of Miami, Bascom Palmer Eye Institute

Miami, Florida, United States

University of Miami Bascom Palmer Eye Institute

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Johns Hopkins, Lions Vision Center

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, United States

University of Minnesota Department of Ophthalmology

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Stony Brook University

East Setauket, New York, United States

Duke University Eye Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Wills Eye Hospital / Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Retina Foundation of the Southwest

Dallas, Texas, United States

Countries

United States

References

Yue L, Wuyyuru V, Gonzalez-Calle A, Dorn JD, Humayun MS. Retina-electrode interface properties and vision restoration by two generations of retinal prostheses in one patient-one in each eye. J Neural Eng. 2020 Apr 9;17(2):026020. doi: 10.1088/1741-2552/ab7c8f.

Reference Type: DERIVED

PMID: 32131056 (View on PubMed)

Gregori NZ, Callaway NF, Hoeppner C, Yuan A, Rachitskaya A, Feuer W, Ameri H, Arevalo JF, Augustin AJ, Birch DG, Dagnelie G, Grisanti S, Davis JL, Hahn P, Handa JT, Ho AC, Huang SS, Humayun MS, Iezzi R Jr, Jayasundera KT, Kokame GT, Lam BL, Lim JI, Mandava N, Montezuma SR, Olmos de Koo L, Szurman P, Vajzovic L, Wiedemann P, Weiland J, Yan J, Zacks DN. Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study. Am J Ophthalmol. 2018 Sep;193:87-99. doi: 10.1016/j.ajo.2018.06.012. Epub 2018 Jun 27.

Reference Type: DERIVED

PMID: 29940167 (View on PubMed)

Other Identifiers

PM-02

Identifier Type: -

Identifier Source: org_study_id