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Argus® II Retinal Prosthesis System Post-Market Surveillance Study

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ClinicalTrials.gov Identifier: NCT01490827
Recruitment Status : Recruiting
First Posted : December 13, 2011
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products

Tracking Information
First Submitted Date December 5, 2011
First Posted Date December 13, 2011
Last Update Posted Date October 9, 2017
Actual Study Start Date November 2011
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2017)
adverse events [ Time Frame: up to 3 years from time of implantation ]
nature and rate of adverse events
Original Primary Outcome Measures
 (submitted: December 12, 2011)
nature and rate of adverse events [ Time Frame: up to 3 years from time of implantation ]
Change History Complete list of historical versions of study NCT01490827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 6, 2017)
visual function [ Time Frame: up to 3 years from time of implantation ]
Square localization, direction of motion, grating visual acuity
Original Secondary Outcome Measures
 (submitted: December 12, 2011)
visual function [ Time Frame: up to 3 years from time of implantation ]
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Argus® II Retinal Prosthesis System Post-Market Surveillance Study
Official Title Argus® II Retinal Prosthesis System Post-Market Surveillance Study
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Outer Retinal Degeneration
  • Retinitis Pigmentosa
Intervention Not Provided
Study Groups/Cohorts Argus II Retinal Prosthesis
Patients implanted with an Argus II Retinal Prosthesis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 12, 2011)
45
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2021
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01490827
Other Study ID Numbers PM-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Second Sight Medical Products
Study Sponsor Second Sight Medical Products
Collaborators Not Provided
Investigators
Study Director: Anne-Marie Ripley Second Sight Medical Products
PRS Account Second Sight Medical Products
Verification Date October 2017