Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

Not Applicable

Recruiting

• Conditions: Primary Open Angle Glaucoma
• Interventions: Procedure: Cataract surgery; Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device

• Registration Number: NCT05564091
• Lead Sponsor: Nova Eye, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-08
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2027-06
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control: Cataract surgery	Cataract surgery	Cataract surgery alone
Cataract surgery combined with ab-interno canaloplasty	Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device	Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)

Primary Outcome Measures

Name	Time	Method
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline	12 months	IOP will be measured at each study visit using Goldmann applanation tonometry
Reduction in number of glaucoma medications at 12 months compared to baseline	12 months	The number of glaucoma medications will be recorded at 12 months compared to baseline

Secondary Outcome Measures

Name	Time	Method
Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline	24 months	IOP will be measured at each study visit using Goldmann applanation tonometry
Reduction in glaucoma medications at 24-months compared to baseline	24 months	The number of glaucoma medications will be recorded at 24-months compared to baseline

Trial Locations

Locations (4)

University of Bonn Eye Clinic; 🇩🇪 Bonn, Germany

Berkeley Eye Center; 🇺🇸 Sugar Land, Texas, United States

St. Johannes Hospital; 🇩🇪 Dortmund, Germany

Augencentrum Köln Ophthalmology; 🇩🇪 Köln, Germany