Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407973
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-06
Brief Title:
A Clinical Trial Comparing the OMNI Surgical System to Standard Medical Treatment in Pseudophakic Eyes
Sponsor:
Sight Sciences Inc
Organization:
Sight Sciences Inc
Study Overview
Official Title:
A Randomized Clinical Trial of ab Interno Canaloplasty and Trabeculotomy With the OMNI Surgical System Compared to Standard Medical Treatment in Pseudophakic Patients With Primary Open Angle Glaucoma
Status:
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:
EVOLVE
Brief Summary:
A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI Surgical System Compared to Standard Medical Treatment in Pseudophakic Patients with Primary Open Angle Glaucoma EVOLVE
Detailed Description:
This prospective multicenter post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS in pseudophakic patients with POAG with DIOP 20 mmHg on prostaglandin monotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None