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

NCT05564091 | Recruiting FDA Device

• 1 other identifier: NE 03021
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 4

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

Keywords

Canaloplasty

Outcome Measures

Primary Outcomes (2)

• Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline

  IOP will be measured at each study visit using Goldmann applanation tonometry

  12 months

• Reduction in number of glaucoma medications at 12 months compared to baseline

  The number of glaucoma medications will be recorded at 12 months compared to baseline

  12 months

Secondary Outcomes (2)

• Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline

  24 months

• Reduction in glaucoma medications at 24-months compared to baseline

  24 months

Study Arms (2)

Cataract surgery combined with ab-interno canaloplasty

ACTIVE COMPARATOR

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

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

Control: Cataract surgery

OTHER

Cataract surgery alone

Procedure: Cataract surgery

Interventions

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

360 degree microcatheterization and viscodilation of Schlemm's canal

Cataract surgery combined with ab-interno canaloplasty

Cataract surgery PROCEDURE

Cataract surgery alone

Also known as: Phacoemulsification

Control: Cataract surgery

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Eye, Inc.: lead
• Nova Eye Medical GmbH: collaborator

Study Sites (4)

Berkeley Eye Center

Sugar Land, Texas, 77478, United States

RECRUITING

University of Bonn Eye Clinic

Bonn, Germany

RECRUITING

Augencentrum Köln Ophthalmology

Cologne, Germany

RECRUITING

St. Johannes Hospital

Dortmund, Germany

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Cataract Extraction; Phacoemulsification

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Norbert Koerber, MD

  Augencentrum Köln Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Pickrel

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: September 8, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); US (1)