New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
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|ClinicalTrials.gov Identifier: NCT01860092|
Recruitment Status : Active, not recruiting
First Posted : May 22, 2013
Last Update Posted : September 26, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||December 2023|
Argus II Retinal Prosthesis
Patients implanted with the Argus II Retinal Prosthesis
- Safety subjects have reached 2 years post-implant. [ Time Frame: 5 Years ]Adverse event rates with the main safety analysis performed when all visits completed
- Visual function [ Time Frame: 5 Years ]Visual function means how to the eye works (e.g. visual acuity). Visual function will be measured using the following test: Square Localization, Direction of Motion and Grating Visual Acuity (GVA).In addition to these tests, a photographic flash test will be performed with the System OFF only to determine if subjects' native residual vision is bare light perception or no light perception.
- Functional Vision [ Time Frame: 5 Years ]Functional vision means how subjects perform in vision-related activities of daily living. Function vision will be assessed using the Functional Low-Vision Observer Rated Assessment (FLORA). A utilization questionnaire will also be administered to track how subjects are using the Argus II System.
- Device Reliability [ Time Frame: 5 Years ]Device reliability will be measured by calculating the rate of implant failure over time.
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): NCT01860092
|Study Director:||Jessy Dorn, PhD||Second Sight Medical Products, Inc.|