Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00407602
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2006-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Argus® II Retinal Stimulation System Feasibility Protocol
Sponsor:
Second Sight Medical Products
Organization:
Study Overview
Official Title:
Argus® II Retinal Stimulation System Feasibility Protocol
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigational Phase of the Study:
The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa.
Post-Approval Phase of the Study:
To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System
The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa.
Post-Approval Phase of the Study:
To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System
Detailed Description:
During the post-approval phase, subjects will undergo annual eye exams, assessments of medical status and adverse events, and measurement of stimulation thresholds. In addition, at the mutual agreement of the investigator and the subject, subjects will have the option of participating in psychophysical research which could occur as frequently as monthly. Functional tests at 10 years: photographic flash, square localization, direction of motion and grating visual acuity.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| National Eye Institute (NEI) | OTHER_GRANT | 2R01EY012893-06A1 | View |