Cataract Surgery With or Without Canaloplasty for Open-Angle Glaucoma
Tests a combined eye surgery with cataract removal in adults with mild to moderate glaucoma.
Plain-language title generated from the registry record
Registry title: Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Key facts
- Where
- Sugar Land, United StatesSee the site
Where in United States
- Berkeley Eye CenterSugar Land, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nova Eye, Inc.
- Trial code
- NCT05564091
- Record updated
- 18 April 2025
- Original description
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.Read full original descriptionShow less
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
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.
Inclusion: 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: 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); Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma; 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).