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

February 14, 2024 updated by: Nova Eye, Inc.
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 12 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bonn, Germany
        • Recruiting
        • University of Bonn Eye Clinic
        • Contact:
          • Karl Mercieca, MD
      • Dortmund, Germany
        • Recruiting
        • St. Johannes Hospital
        • Contact:
          • Markus Kohlhaas, MD
      • Köln, Germany
        • Recruiting
        • Augencentrum Köln Ophthalmology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)
  • Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN)
  • 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, pigmentary glaucoma or pseudo exfoliative glaucoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cataract surgery combined with ab-interno canaloplasty
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
360 degree microcatheterization and viscodilation of Schlemm's canal
Other: Control: Cataract surgery
Cataract surgery alone
Procedure: Cataract surgery
Cataract surgery alone
Other Names:
  • Phacoemulsification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
Time Frame: 12 months
IOP will be measured at each study visit using Goldmann applanation tonometry
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the reduction in number of glaucoma medications at 12 months compared to baseline
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Eye, Inc.

Collaborators

Nova Eye Medical GmbH

Investigators

  • Principal Investigator: Norbert Koerber, MD, Augencentrum Köln Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE 03021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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