Multicenter Glaucoma Study Investigating Standalone Canaloplasty

NCT05786196 | Recruiting FDA Device

• 1 other identifier: NE 05021
• Study Type: interventional
• Target: 86
• Locations: 3 countries
• Sites: 5

Brief Summary

A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.

Conditions

Primary Open Angle Glaucoma

Keywords

Canaloplasty

Outcome Measures

Primary Outcomes (2)

• The mean change in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline

  IOP will be measured at each visit with Goldmann applanation tonometry

  12 months

• Percentage of eyes achieving a 20% or greater reduction in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline and without any other intervention (medication or secondary surgery)

  IOP will be measured at each visit with Goldmann applanation tonometry

  12 months

Study Arms (2)

iTrack Advance

ACTIVE COMPARATOR

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

Device: Ab-interno canaloplasty utilizing the iTrack Advance device

OMNI Surgical System

ACTIVE COMPARATOR

Ab-interno canaloplasty utilizing the OMNI Surgical System

Device: Ab-interno canaloplasty utilizing the OMNI Surgical System

Interventions

Ab-interno canaloplasty utilizing the iTrack Advance device DEVICE

360 degree microcatheterization and viscodilation of Schlemm's canal

iTrack Advance

Ab-interno canaloplasty utilizing the OMNI Surgical System DEVICE

360 degree microcatheterization and viscodilation of Schlemm's canal

OMNI Surgical System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 22 years or older at the time of surgery
• Diagnosed with mild to moderate primary open angle glaucoma
• Candidate for canaloplasty surgery: i.e., catheterization of Schlemm's canal and subsequent viscodilation of Schlemm's canal, without trabeculotomy
• Intolerance to medical therapy OR need/willingness to reduce medications
• At the Screening Visit, IOP of ≤ 30 mmHg while on 1-4 ocular hypotensive medications
• At the Baseline Visit, unmedicated IOP ≥ 21mmHg and ≤ 36 mmHg, and ≥ 3mmHg higher than medicated IOP
• Shaffer grade of ≥ 3 in all four quadrants
• Central corneal thickness ≥ 480µm and ≤ 620 µm
• Able and willing to comply with the study procedures and attend all follow-up visits
• Understands and signs the informed consent

You may not qualify if:

• Any of the following prior treatments for glaucoma (study eye):
• Laser trabeculoplasty
• i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty
• iStent or iStent Inject within 180 days of the Screening Visit
• Endocyclophotocoagulation (ECP) or Micropulse laser
• Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve
• Prior canaloplasty (ab interno and ab externo)
• Prior goniotomy, or trabeculotomy (ab externo and ab interno)
• Hydrus microstent
• Suprachoroidal stent (e.g., Cypass, iStent Supra, MINIject)
• Concurrent IOP-lowering procedure other than use of the iTrack Advance canaloplasty device OR the OMNI Surgical System at the time of surgery (e.g., ECP, CPC, etc.)
• Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudoexfoliative glaucoma
• Cataract surgery within 6 months of the Screening Visit in the study eye
• History of fellow eye with cataract surgery within 30 days of Screening
• Subjects at significant risk by a washout of ocular hypotensive medication, and/or subjects where the unmedicated IOP is expected to exceed the upper limit of 36 mmHg

Sponsors & Collaborators

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

Study Sites (5)

Breyer Kaymak Klabe Augenchirurgie

Düsseldorf, Germany

RECRUITING

Hospital Clinico San Carlos, Servicio de Oftalmologia

Madrid, Spain

RECRUITING

Princess Alexandra Eye Pavilion, NHS Lothian

Edinburgh, United Kingdom

RECRUITING

St. Paul's Eye Unit, Liverpool University

Liverpool, United Kingdom

RECRUITING

Manchester Royal Eye Hospital

Manchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Shamil Patel, MD, MBA

  Eye Physicians and Surgeons of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Pickrel

CONTACT

1-800-391-2316; mpickrel@nova-eye.com

Study Design

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

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: May 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (1); GB (3)