Observational Study of the Argus® II Retinal Prosthesis System
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|ClinicalTrials.gov Identifier: NCT01999049|
Recruitment Status : Unknown
Verified April 2015 by University Health Network, Toronto.
Recruitment status was: Recruiting
First Posted : December 3, 2013
Last Update Posted : April 24, 2015
|Condition or disease|
This study is an investigator-sponsored, observational, controlled, prospective, single-center study. The purpose of this current study is how it affects people's visual function and activities of daily living and to collect additional data on Argus II users in order to monitor the System's safety. In addition, data about the long-term reliability of the System will be gathered.
The Argus II retinal implant will be surgical implanted into patients who are blind but the surgical procedure is not a part of this observational study. Our hypothesis is that the visual results in our hands will be comparable to those reported in the FDA study. We will use the results of this study to plan future enhancements to the service and to explore the use of the device for other blinding conditions.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Observational Study of the Argus® II Retinal Prosthesis System|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2017|
- Safety [ Time Frame: Patients will be observed for 1 year post-implant. ]The primary endpoint in the study is safety. Safety will be assessed by calculating the proportion of subjects who experience individual procedure- and device-related adverse events. In addition, the proportion of subjects who experience a significant ocular event will also be reported.
- Visual function [ Time Frame: 1 year ]
- Visual function: Visual function means how the eye works (e.g. visual acuity). Visual function will be measured using the following tests: Square Localization; Direction of Motion; Grating Visual Acuity (GVA).
- Functional vision: 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.
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): NCT01999049
|Contact: Robert Devenyi, MDfirstname.lastname@example.org|
|UHN Toronto Western Hospital 6E-438||Recruiting|
|Toronto, Ontario, Canada, M5t 2S8|
|Principal Investigator: Robert Devenyi, MD|
|Principal Investigator:||Robert Devenyi, MD||University Health Network- Toronto Western Hospital|