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

Sponsor
Nova Eye, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05564091
Collaborator
Nova Eye Medical GmbH (Industry)
78
Enrollment
1
Location
2
Arms
17.7
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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 12 months.

Condition or Disease Intervention/Treatment Phase
  • Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
  • Procedure: Cataract surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Actual Study Start Date :
Sep 8, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline [12 months]

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

    Secondary Outcome Measures

    1. To evaluate the reduction in number of glaucoma medications at 12 months compared to baseline [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Augencentrum Köln Ophthalmology Köln Germany

    Sponsors and Collaborators

    • Nova Eye, Inc.
    • Nova Eye Medical GmbH

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nova Eye, Inc.
    ClinicalTrials.gov Identifier:
    NCT05564091
    Other Study ID Numbers:
    • NE 03021
    First Posted:
    Oct 3, 2022
    Last Update Posted:
    Oct 17, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Nova Eye, Inc.
    Canaloplasty
    Additional relevant MeSH terms:
    Glaucoma
    Cataract
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of Oct 17, 2022