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

Description

This is a controlled (with Argus II System turned ON and OFF) prospective, multi-center post HUD approval study. The objective is to study the overall safety and utility results for the Argus II System implanted in the general population and are the safety and utility results similar or different to results from observed subjects enrolled in the pre-market study. There will be a total of 53 participants, blind from retinitis pigmentosa and implanted with the HUD Argus II System, that will be asked to enroll. It is anticipated that 85% of subjects will complete 5 years follow-up. This will provide a sample size of 45 subjects with complete 5 year follow-up. A minimum of 5 and a maximum of 20 centers in the US will participate in this study. The participant will have tests and exams including review of medical history, medical exam, eye exam, grating visual acuity, square localization, direction of motion, ultrasound, and flash test. They will have the option to undergo photography, and imaging.They will have the exam at 8 follow up visits: 1month, 3month, 6month, 1yr, 2yr, 3yr, 4yr, 5yr.The study endpoints are Primary: Safety (i.e. adverse event rates), with the main safety analysis performed when all subjects have reached 2 years post-implant. Secondary: Visual function, functional vision, and device reliability. Statistics: Descriptive summaries will be provided for all data including subject demographics, adverse events, visual function, and functional vision.Continuous variables will be summarized with their means, medians, standard deviations, and ranges over time. Categorical variables will be summarized with their proportions and confidence intervals.

Phase

N/A

Inclusion and Exclusion 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.

Sites

  • Baden-Wurttemberg

    • Augenklinik des Staedtischen Klinikums, Karlsruhe, Baden-Wurttemberg, 76133
  • Germany

    • RWTH University Eye Clinic, Aachen, 52074
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