NCT05564091

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Nova Eye, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-09-08
• Primary completion: 2027-06-01
• Completion: 2027-07-01
• First posted: 2022-10-03
• Last updated: 2025-04-18

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study