NCT03861169

Study of OMNI System in OAG (GEMINI)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Sight Sciences, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Transluminal viscoelastic delivery and trabeculotomy	Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System

Timeline

• Start date: 2019-03-11
• Primary completion: 2021-05-04
• Completion: 2021-05-04
• First posted: 2019-03-04
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study