Actively Recruiting
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Led by Nova Eye, Inc. · Updated on 2025-04-18
78
Participants Needed
4
Research Sites
251 weeks
Total Duration
On this page
Sponsors
N
Nova Eye, Inc.
Lead Sponsor
N
Nova Eye Medical GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Prior glaucoma treatments in the study eye including laser trabeculoplasty, endocyclophotocoagulation, micropulse laser, iStent or iStent Inject, Hydrus Microstent, trabeculectomy or other bleb forming procedures such as Xen, Express, and glaucoma drainage devices
- Prior canaloplasty (ab-interno and ab-externo)
- Prior goniotomy or trabeculotomy (ab-interno or ab-externo)
- Use of suprachoroidal stents (e.g., Cypass, iStent Supra, XEN, MINIject)
- Concurrent IOP-lowering procedures other than iTrack Advance canaloplasty at time of surgery
- Previous treatment with iTrack device in the study eye (allowed if only fellow eye treated)
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Berkeley Eye Center
Sugar Land, Texas, United States, 77478
Actively Recruiting
2
University of Bonn Eye Clinic
Bonn, Germany
Actively Recruiting
3
Augencentrum Köln Ophthalmology
Cologne, Germany
Actively Recruiting
4
St. Johannes Hospital
Dortmund, Germany
Actively Recruiting
Research Team
M
Mike Pickrel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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