Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 10:42 AM
Study NCT ID:
NCT03861169
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of OMNI System in OAG (GEMINI)
Sponsor:
Sight Sciences, Inc.
Organization:
Study Overview
Official Title:
Prospective, Multi-Center, Single-Arm Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
Status:
COMPLETED
Status Verified Date:
2024-07
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:
This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).
Detailed Description:
This prospective, multicenter, single-arm, post-market clinical study will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive medications in patients with mild to moderate open angle glaucoma.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: