Actively Recruiting
Cataract Surgery With Ab-interno Canaloplasty Using iTrack Advance Compared to Cataract Surgery Alone in Mild to Moderate Primary Open-Angle Glaucoma
Led by Nova Eye, Inc. · Updated on 2025-04-18
78
Participants Needed
4
Research Sites
4 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
Researchers are evaluating cataract surgery combined with ab-interno canaloplasty using the iTrack Advance canaloplasty device compared to cataract surgery alone in patients with mild to moderate primary open-angle glaucoma. This prospective, multicenter, randomized, single-masked clinical trial aims to assess the effects of these treatments on eye pressure and glaucoma medication use over a two-year period. Participants will be randomly assigned to one of two groups: cataract surgery with ab-interno canaloplasty, which involves 360-degree microcatheterization and viscodilation of Schlemm's canal using the iTrack Advance device, or cataract surgery alone. The study will monitor the impact of these procedures on intraocular pressure and the number of glaucoma medications needed. During the 24-month follow-up, participants will undergo regular assessments to measure changes in intraocular pressure and medication use at 12 and 24 months compared to baseline. The study will also track safety and treatment effects. Participants can expect scheduled visits to monitor eye health and study outcomes throughout their involvement.
CONDITIONS
Brief 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 to 4 ocular hypotensive medications at screening
- Presence of a visually significant cataract
You will not qualify if you...
- Prior laser trabeculoplasty in the study eye
- Prior endocyclophotocoagulation or micropulse laser in the study eye
- Prior iStent or iStent Inject in the study eye
- Prior Hydrus Microstent in the study eye
- Prior trabeculectomy or other bleb-forming procedures including Xen, Express, or glaucoma drainage devices
- Prior canaloplasty (ab-interno or ab-externo) in the study eye
- Prior goniotomy or trabeculotomy (ab-interno or ab-externo) in the study eye
- Prior suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject) in the study eye
- Concurrent intraocular pressure-lowering procedures other than iTrack Advance at the time of surgery
- Previous treatment with iTrack in the study eye (permitted if only the fellow eye was treated)
- Diagnosis of 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day to 1 week
Participants undergo cataract surgery, either alone or combined with ab-interno canaloplasty using the iTrack Advance device, followed by immediate post-operative care.
1 surgery visit and approximately 2 post-operative visits
Duration - Up to 24 months
Participants attend follow-up visits to monitor recovery, intraocular pressure, and medication use after surgery.
Regular follow-up visits over 24 months
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
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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