NCT04616573

A Post-market Study Of Use Of The OMNI® Surgical System In Open Angle Glaucoma

A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Sight Sciences, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.

Detailed description

First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DEVICE	OMNI® Surgical System	Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
DEVICE	iStent inject	Trabecular meshwork implantation

Timeline

• Start date: 2020-11-13
• Primary completion: 2021-01-20
• Completion: 2021-01-20
• First posted: 2020-11-05
• Last updated: 2022-12-01
• Results posted: 2022-12-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study