RecruitingNot ApplicableNCT05786196

Multicenter Glaucoma Study Investigating Standalone Canaloplasty

Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)


Sponsor

Nova Eye, Inc.

Enrollment

86 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a glaucoma surgery called canaloplasty, which involves gently stretching and widening the eye's natural drainage channel to lower eye pressure — without cutting the eye like traditional surgery. Researchers want to see how well it works as a standalone procedure. **You may be eligible if...** - You are 22 years or older - You have been diagnosed with mild to moderate open-angle glaucoma - You are intolerant of eye drop medications or want to reduce how many you take - Your eye pressure while off medications is between 21 and 36 mmHg - You are willing to undergo canaloplasty surgery **You may NOT be eligible if...** - You have had prior glaucoma laser treatments (like SLT or argon laser) or previous glaucoma surgery - You have previously had a canaloplasty or similar drainage procedure - You have certain eye conditions affecting the cornea or drainage structures - You are pregnant - You have been on certain medications that could affect the eye within the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAb-interno canaloplasty utilizing the iTrack Advance device

360 degree microcatheterization and viscodilation of Schlemm's canal

DEVICEAb-interno canaloplasty utilizing the OMNI Surgical System

360 degree microcatheterization and viscodilation of Schlemm's canal


Locations(5)

Breyer Kaymak Klabe Augenchirurgie

Düsseldorf, Germany

Hospital Clinico San Carlos, Servicio de Oftalmologia

Madrid, Spain

Princess Alexandra Eye Pavilion, NHS Lothian

Edinburgh, United Kingdom

St. Paul's Eye Unit, Liverpool University

Liverpool, United Kingdom

Manchester Royal Eye Hospital

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05786196


Related Trials