Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02227498|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2014
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Device: Effect of Argus II on Functional Vision||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Effect of Argus II on Functional Vision
All subjects enrolled in the study will be implanted with the Argus II Retinal Prosthesis. To evaluate safety and effectiveness of Argus II on visual function.
Device: Effect of Argus II on Functional Vision
To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.
- Adverse Events [ Time Frame: Up to 1 year ]The number of adverse events in implanted subjects.
- Visual function [ Time Frame: 1 Year ]The primary effectiveness endpoint of the study is the effect of the Argus II System on monocular (implanted eye) and binocular visual function, as measured by a suite of visual function tests.
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): NCT02227498
|Manchester Royal Eye Hospital|
|Manchester, United Kingdom, M13 9WL|
|Study Director:||Jessy Dorn, PhD||Second Sight Medical Products, Inc.|