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Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

NCT04769453 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-15

No results posted yet for this study

Summary

A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).

Conditions

  • Primary Open Angle Glaucoma

Interventions

DEVICE

Canaloplasty using the iTrack microcatheter with Healon GV Pro

360 degree microcatheterization and viscodilation of Schlemm's canal

DEVICE

Canaloplasty using the Omni surgical system with Healon GV Pro

360 degree microcatheterization and viscodilation of Schlemm's canal

DEVICE

Canaloplasty using the iTrack microcatheter with Healon Pro

360 degree microcatheterization and viscodilation of Schlemm's canal

DEVICE

Canaloplasty using the Omni surgical system with Healon Pro

360 degree microcatheterization and viscodilation of Schlemm's canal

Sponsors & Collaborators

  • 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
FACTORIAL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2023-01-26
Completion
2023-01-26
FDA Device
Yes

Countries

  • United States

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 NCT04769453 on ClinicalTrials.gov