Retinitis Pigmentosa Clinical Trial
Official title:
Post-Market Study of the Argus® II Retinal Prosthesis System - France
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.
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.
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