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Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT05564091•Nova Eye, Inc.

View on ClinicalTrials.gov

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

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

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.)
+2 more criteria

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

Key Dates

Start Date

September 8, 2022

Primary Completion Date

June 1, 2027

Completion Date

July 1, 2027

Last Updated

April 18, 2025

Enrollment

ESTIMATED participants

Conditions

Primary Open Angle Glaucoma

Interventions

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

DEVICE

Cataract surgery

PROCEDURE

Contacts

Mike Pickrel

CONTACT

800-391-2316 MPickrel@Nova-Eye.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

DSLT for Reducing Medication in Glaucoma

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

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