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Multicenter Glaucoma Study Investigating Standalone Canaloplasty

NCT05786196 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-04-18

No results posted yet for this study

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

Interventions

DEVICE

Ab-interno canaloplasty utilizing the iTrack Advance device

360 degree microcatheterization and viscodilation of Schlemm's canal

DEVICE

Ab-interno canaloplasty utilizing the OMNI Surgical System

360 degree microcatheterization and viscodilation of Schlemm's canal

Sponsors & Collaborators

  • Nova Eye Medical GmbH

    collaborator INDUSTRY

  • Nova Eye, Inc.

    lead INDUSTRY

Principal Investigators

  • Shamil Patel, MD, MBA · Eye Physicians and Surgeons of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786196 on ClinicalTrials.gov