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Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Recruiting
Who can join
Ages 55 and older · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device (device)
- Cataract surgery (procedure)
Sponsor: Nova Eye, Inc. · Participants: 78 · Started: Sep 8, 2022
Contact the study team
- Mike Pickrel · Phone: 800-391-2316
Official record on ClinicalTrials.gov — NCT05564091
Locations in the U.S.
| Texas | Berkeley Eye Center, Sugar Land |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.