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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05564091
Other study ID # NE 03021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2022
Est. completion date October 2025

Study information

Verified date February 2024
Source Nova Eye, Inc.
Contact Mike Pickrel
Phone 800-391-2316
Email MPickrel@Nova-Eye.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date October 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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 Design


Intervention

Device:
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
360 degree microcatheterization and viscodilation of Schlemm's canal
Procedure:
Cataract surgery
Cataract surgery alone

Locations

Country Name City State
Germany University of Bonn Eye Clinic Bonn
Germany St. Johannes Hospital Dortmund
Germany Augencentrum Köln Ophthalmology Köln

Sponsors (2)

Lead Sponsor Collaborator
Nova Eye, Inc. Nova Eye Medical GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline IOP will be measured at each study visit using Goldmann applanation tonometry 12 months
Secondary To evaluate the reduction in number of glaucoma medications at 12 months compared to baseline 12 months
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