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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Argus II Retinal Prosthesis
Patients implanted with an Argus II Retinal Prosthesis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Sight Medical Products

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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