Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-26 @ 9:35 PM
Study NCT ID:
NCT06597292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-25
First Post:
2024-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.
Sponsor:
VIS, Inc.
Organization:
Study Overview
Official Title:
Vision Improvement for Patients With Presbyopia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Opti-K Pres
Brief Summary:
The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: