RecruitingNot ApplicableNCT05564091

Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma


Sponsor

Nova Eye, Inc.

Enrollment

78 participants

Start Date

Sep 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing cataract surgery combined with a minimally invasive glaucoma procedure (ab-interno canaloplasty, which opens up the eye's natural drainage channel using a tiny catheter) versus cataract surgery alone in people with mild to moderate open-angle glaucoma. The goal is to see if the combined procedure better lowers eye pressure and reduces reliance on eye drops. **You may be eligible if...** - You have mild to moderate primary open-angle glaucoma - You are using 1 to 4 eye pressure–lowering medications and still need better pressure control - You have a cataract that is affecting your vision **You may NOT be eligible if...** - You have had prior glaucoma surgery, laser treatments, or stent implantation in the study eye - You have a prior canaloplasty in the same eye - You have angle-closure, traumatic, inflammatory (uveitic), or neovascular glaucoma 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.

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Interventions

DEVICECataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device

360 degree microcatheterization and viscodilation of Schlemm's canal

PROCEDURECataract surgery

Cataract surgery alone


Locations(4)

Berkeley Eye Center

Sugar Land, Texas, United States

University of Bonn Eye Clinic

Bonn, Germany

Augencentrum Köln Ophthalmology

Cologne, Germany

St. Johannes Hospital

Dortmund, Germany

View Full Details on ClinicalTrials.gov

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NCT05564091


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