Cataract surgery combined with canaloplasty for glaucoma patients
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
This study is testing whether combining cataract surgery with a special glaucoma procedure can help people with mild to moderate glaucoma manage their eye pressure better than just cataract surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Nova Eye, Inc. Industry-sponsored |
| Locations | 4 sites (Sugar Land, Texas and 3 other locations) |
| Trial ID | NCT05564091 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the outcomes of cataract surgery performed alongside ab-interno canaloplasty using the iTrack Advance device against cataract surgery alone in patients with mild to moderate primary open-angle glaucoma. It is a multicenter, randomized, single-masked trial that will follow participants for 24 months to assess the effectiveness of the combined procedure. The goal is to determine if the addition of canaloplasty can improve intraocular pressure management in these patients.
Who should consider this trial
Good fit: Ideal candidates include individuals with mild to moderate primary open-angle glaucoma who also have visually significant cataracts.
Not a fit: Patients who have previously undergone certain glaucoma surgeries or treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance glaucoma management and improve visual outcomes for patients undergoing cataract surgery.
How similar studies have performed: While there have been studies on cataract surgery and glaucoma treatments, this specific combination approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: Any of the following prior treatments for glaucoma (study eye): * 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. * Prior canaloplasty (ab-interno and ab-externo) * Prior goniotomy, or trabeculotomy (ab-interno or ab-externo) * Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject) * 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) * Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Where this trial is running
Sugar Land, Texas and 3 other locations
- Berkeley Eye Center — Sugar Land, Texas, United States (Recruiting)
- University of Bonn Eye Clinic — Bonn, Germany (Recruiting)
- Augencentrum Köln Ophthalmology — Cologne, Germany (Recruiting)
- St. Johannes Hospital — Dortmund, Germany (Recruiting)
Study contacts
- Principal investigator: Norbert Koerber, MD — Augencentrum Köln Ophthalmology
- Study coordinator: Mike Pickrel
- Email: MPickrel@Nova-Eye.com
- Phone: 800-391-2316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.