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NCT05564091NARecruiting

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

Nova Eye, Inc.

Start Date

9/8/2022

Completion Date

7/1/2027

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 Criteria

Age Range: 55 years to No maximum

Inclusion Criteria: * Mild to moderate, primary open angle glaucoma * Characteristics consistent with mild to moderate glaucoma * Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria * Visually significant cataract Exclusion Criteria: Any of the following prior treatments for glaucoma (study eye): * Laser Trabeculoplasty * Endocyclophotocoagulation (ECP) or Micropulse laser * iStent or iStent Inject * Hydrus Microstent * Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve. * Prior canaloplasty (ab-interno and ab-externo) * Prior goniotomy, or trabeculotomy (ab-interno or ab-externo) * Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject) * Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.) * Previous treatment with iTrack (Note: permitted if fellow eye only was treated) * Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma

Interventions

DEVICE

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

PROCEDURE

Cataract surgery

Interested in This Trial?

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Conditions

Primary Open Angle Glaucoma

Locations

Berkeley Eye Center

Sugar Land, Texas 77478

United States

University of Bonn Eye Clinic

Bonn,

Germany

Augencentrum Köln Ophthalmology

Cologne,

Germany

St. Johannes Hospital

Dortmund,

Germany