Recruiting

Canaloplasty & Cataract

Sponsor:

Nova Eye, Inc.

Code:

NCT05564091

Conditions

Primary Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device

Cataract surgery

Study Details

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.

Conditions

Primary Open Angle Glaucoma

Study ID

NCT05564091

Start date

Sep 8, 2022

Status verified date

Apr, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cataract surgery combined with ab-interno canaloplasty

Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)

other: Control: Cataract surgery

Cataract surgery alone

Interventions

Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device

360 degree microcatheterization and viscodilation of Schlemm's canal

Cataract surgery

Cataract surgery alone

Primary outcome measure

  • Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline [ Time Frame: 12 months ]
  • Reduction in number of glaucoma medications at 12 months compared to baseline [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Mike Pickrel

800-391-2316MPickrel@Nova-Eye.com

Locations

Berkeley Eye Center

Recruiting

Sugar Land, Texas, United States, 77478

More Information

Sponsor

Nova Eye, Inc.

Last update posted

Apr 18, 2025

Last verified

Apr, 2025

Keywords

  • Canaloplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Eye, Inc. on 2025-04-18.