NCT02303288

Post-Market Study of the Argus® II Retinal Prosthesis System - France

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Second Sight Medical Products · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This is a post-market study of the Argus II Retinal Prosthesis System. The study is being conducted in France. The objective of the study is to obtain data to further demonstrate the effectiveness and evaluate the safety of Argus II System in patients with retinitis pigmentosa who have a bare light perception or worse in both eyes.

Detailed description

This study is a controlled, prospective, multi-centre, single-arm post-market study. All data collected will be obtained from procedures that are performed as part of routine patient case and from non-interventional questionnaires. Control will consist of three different matched comparisons: * Post vs. pre-implantation (Baseline) data. * Prospective within-subject comparisons (implanted vs. non implanted eye) * Prospective subjects' visual performance Argus II System ON vs Argus II System OFF. Subjects participating in the study will undergo a Baseline Visit. The Baseline Visit is performed to screen the subject for eligibility for the device and to collect the study baseline assessments. Assessments include a complete eye examination and medical evaluation, retinal photography and Optical Coherence Tomography, Ultrasound A- and B-scans, the photographic flash test, visual acuity tests, the FLORA and a psychosocial evaluation in order to ensure that the subject has realistic expectations about the system. The NEI-VFQ-25 questionnaire will also be administered. Subjects who are enrolled in the study will undergo a surgery to have the Argus II device implanted. Following implantation surgery, subjects will return to the clinic for periodic clinical follow-up and device fitting. They will also receive training and visual rehabilitation. Clinical follow-up visits will take place 1 and 2 weeks, 1, 3, 6, 12 and 24 months post-implant. Examinations and tests will be performed as at baseline. In addition, a patient satisfaction, Ease of Use, and Utilization of the System Questionnaire will be administered. Most of the visual function tests and measures will be conducted in both the implanted and fellow eye to provide data on the natural course of the participants' vision loss and as a control for measurements of visual function. In addition, the visual function tests and the FLORA will be done for the implanted eye with the device ON as well as OFF. Device Fitting refers to the procedure for customizing the Video Processing Unit (VPU) for use by the subject. Device Fitting is typically begins one week post-implant and is completed in approximately 4 sessions. Beginning approximately one month post-implant, subjects will receive training on how to use the Argus II System. There are two phases of training: system training and visual rehabilitation. During system training, subjects learn basic skills: how to connect the glasses to the VPU, change battery etc., how to control eye movements and RF link, how to scan the environment with head movements and how to use different filters and switch between program settings. During visual rehabilitation, subjects learn how to integrate the use of the Argus II System into their everyday life. Visual rehabilitation sessions will be provided by certified low-vision therapists and/or orientation and mobility specialists and will take place both at the clinic and the subject's home.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DEVICE	Argus II Retinal Prosthesis System	The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.

Timeline

• Start date: 2014-11-20
• Primary completion: 2018-03-20
• Completion: 2018-11-20
• First posted: 2014-11-27
• Last updated: 2020-06-22

Locations

3 sites across 1 country: France