Argus II Retinal Prosthesis System - Better Vision RP 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03418116|
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : September 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Device: Argus II Retinal Prosthesis||Not Applicable|
The Argus II System is intended for use in blind patients with severe to profound retinitis pigmentosa with at least some light perception in the eye to be implanted.
The majority of RP patients still have some central vision even at a very late stage of the disease. This extremely restricted visual field is, however, highly disabling in daily life. The primary objective of this study is to evaluate the safety and benefit of the Argus II System in RP patients characterized as late stage with a central residual visual field smaller than or equal to 5 degrees radius . The electrode array will be placed in a para- to peri foveal location adjacent to the subject's residual visual field, thus increasing the total retinal area receptive to light.
Safety data will be monitored to ensure continued acceptability of risks to study subjects and visual function will be measured to evaluate the effectiveness of the system in this "better vision" RP population. In addition, effects on functional vision and quality of life will be assessed through the Functional Low-Vision Observer Rated Assessment (FLORA) and the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Argus II Retinal Prosthesis System - Better Vision RP Study|
|Estimated Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: Argus II
Implantation of the Argus II Retinal Prosthesis in patients with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius. The array will be placed parafoveally, adjacent to the preserved central visual field (i.e., "tunnel vision") in these subjects.
Device: Argus II Retinal Prosthesis
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.
- Adverse events [ Time Frame: 2 Years ]The nature and number of adverse events in implanted subjects.
- Visual field [ Time Frame: 2 Years ]The effect of the Argus II System on visual field size, as measured by Goldmann perimetry
- Visual function [ Time Frame: 2 Years ]Effect of the Argus II System on visual function, as measured by a suite of visual tests
- Quality of Life [ Time Frame: 2 Years ]Effect of the Argus II System on quality of life, as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
- Functional vision and quality of life [ Time Frame: 2 Years ]The general impact of the Argus II on subject's lives, as measured by the Functional Low-Vision Observer Rated Assessment (FLORA)
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): NCT03418116
|Contact: Nancy Ouch||818 firstname.lastname@example.org|
|Contact: Annette Bastian, PhD||+41 21 353 email@example.com|
|Augenklinik Städtisches Klinikum Karlsruhe||Recruiting|
|Karlsruhe, Baden-Wurttemberg, Germany, 76133|
|Contact: Jenny Atorf, Dr. rer. nat +49-721-974-2034 firstname.lastname@example.org|
|Principal Investigator: Albert J Augustin, Prof Dr med|
|University Medical Center Schleswig-Holstein, Department of Ophthalmology||Recruiting|
|Lübeck, Schleswig-Holstein, Germany, 23538|
|Contact: Nadine Schoenberg +49 451 500 43913 email@example.com|
|Principal Investigator: Salvatore Grisanti, Prof Dr med|
|RWTH University Eye Clinic||Recruiting|
|Aachen, Germany, 52074|
|Contact: Kim Schaffrath, M.D. +49-241-8088192 firstname.lastname@example.org|
|Principal Investigator: Peter Walter, Prof Dr med|
|Principal Investigator:||Peter Walter, Prof Dr med||RWTH Aachen University|