Argus® II Retinal Prosthesis System Post-Market Surveillance Study

May 19, 2020 updated by: Second Sight Medical Products
This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.

Study Overview

Status

Terminated

Conditions

Detailed Description

This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • RWTH University Eye Clinic
      • Hamburg, Germany, 20246
        • University Hospital Hamburg-Eppendorf, Klinik u. Poliklinik fur Augenheilkunde
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde
    • Baden-Wurttemberg
      • Karlsruhe, Baden-Wurttemberg, Germany, 76133
        • Augenklinik des Staedtischen Klinikums
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum rechts der Isar - Technical University
    • NRW
      • Koln, NRW, Germany, 50924
        • Center for Ophthalmology - University of Koln
    • Saarland
      • Sulzbach, Saarland, Germany, 66280
        • Knappschaftsklinikum Saar, Department of Ophthalmology
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • University Medical Center Schleswig-Holstein, Department of Ophthalmology
  • Italy
    • Toscana
      • Pisa, Toscana, Italy, 56100
        • University of Pisa Eye Surgery Department
    • Veneto
      • Camposampiero, Veneto, Italy, 35012
        • ULSS 15 Alta Padovana Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be selected from eligible patients who have been implanted with the Argus II retinal prosthesis at the enrolling center.

Description

Inclusion Criteria:

Adults, age 25 year or older

  • with severe to profound outer retinal degeneration (not including Age-related Macular Degeneration)
  • Have some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation;
  • Have previous history of useful form vision
  • Have consented to participate in the study
  • Had an Argus II Retinal Prosthesis surgically implanted 14 days (± 7 days) prior to enrollment (at Baseline Visit) in the study
  • At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).

Exclusion Criteria:

  • Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.)
  • 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; choroidal neovascularization in the area of the intended tack location, etc.)
  • Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity)
  • 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 or selective frequency hearing loss that prevents hearing device alarms and alerts
  • Participants who are pregnant or wish to become pregnant during the course of the study
  • Participation 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: up to 3 years from time of implantation
nature and rate of adverse events
up to 3 years from time of implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual function
Time Frame: up to 3 years from time of implantation
Square localization, direction of motion, grating visual acuity
up to 3 years from time of implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Sight Medical Products

Investigators

  • Study Director: Anne-Marie Ripley, Second Sight Medical Products

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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