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

NCT04658095 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-27

Study results available
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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.

Conditions

  • Glaucoma, Open-Angle

Interventions

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

Sponsors & Collaborators

  • Sight Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Jaime Dickerson, PhD · Sight Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2022-11-18
Completion
2022-11-18
FDA Device
Yes

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658095 on ClinicalTrials.gov