NCT05564091Recruiting
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Source: ClinicalTrials.gov · Last updated 18 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 29 Sept 2022
- Start date
- 8 Sept 2022
- Primary completion date
- Jun 2027
- Lead sponsor
- Nova Eye, Inc.
- Diseases
- Glaucoma
- NCT number
- NCT05564091
What you commit to
- Study type: Interventional
- Planned participants: 78
- From 8 Sept 2022 to the primary completion date, Jun 2027
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any of the following prior treatments for glaucoma (study eye):
- Prior canaloplasty (ab-interno and ab-externo)
- Prior goniotomy, or trabeculotomy (ab-interno or ab-externo)
- Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.)
- Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
Other illness
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Other
- 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.
- Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject)
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Bonn Eye Clinic Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Augencentrum Köln Ophthalmology Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| St Johannes Hospital Coordinator of this site? Confirm its status | Dortmund | Germany | Recruiting |
| Berkeley Eye Center Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.