NCT04658095

Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)

A Prospective, Randomized, Multicenter Study To Compare The Safety And Effectiveness Of The OMNI® Surgical System And The iStent Inject In Pseudophakic Eyes With Open Angle Glaucoma. The TRIDENT European Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sight Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.

Detailed description

A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DEVICE	Canaloplasty and trabeculotomy with the OMNI system.	Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy
DEVICE	iStent inject	Ab-interno implantation of iStent inject (2 microstents)
DEVICE	Canaloplasty	Ab-interno canaloplasty (360 degrees) using the OMNI

Timeline

• Start date: 2022-01-11
• Primary completion: 2022-11-18
• Completion: 2022-11-18
• First posted: 2020-12-08
• Last updated: 2025-10-27
• Results posted: 2025-10-27

Locations

5 sites across 3 countries: Germany, Spain, United Kingdom

Regulatory

• FDA-regulated device study