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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

NCT05564091 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-04-18

No results posted yet for this study

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.

Conditions

  • Primary Open Angle Glaucoma

Interventions

DEVICE

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

360 degree microcatheterization and viscodilation of Schlemm's canal

PROCEDURE

Cataract surgery

Cataract surgery alone

Sponsors & Collaborators

  • Nova Eye Medical GmbH

    collaborator INDUSTRY

  • Nova Eye, Inc.

    lead INDUSTRY

Principal Investigators

  • Norbert Koerber, MD · Augencentrum Köln Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2027-06-30
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States
  • Germany

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 NCT05564091 on ClinicalTrials.gov