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Argus® II Retinal Prosthesis System Post-Market Surveillance Study

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: NCT01490827
Recruitment Status : Active, not recruiting
First Posted : December 13, 2011
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products

Brief Summary:
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.

Condition or disease
Outer Retinal Degeneration Retinitis Pigmentosa

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.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Argus® II Retinal Prosthesis System Post-Market Surveillance Study
Actual Study Start Date : November 2011
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

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



Primary Outcome Measures :
  1. adverse events [ Time Frame: up to 3 years from time of implantation ]
    nature and rate of adverse events


Secondary Outcome Measures :
  1. visual function [ Time Frame: up to 3 years from time of implantation ]
    Square localization, direction of motion, grating visual acuity



Information from the National Library of Medicine

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

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.

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): NCT01490827


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

Publications:
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: NCT01490827     History of Changes
Other Study ID Numbers: PM-01
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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