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

Primary Open Angle Glaucoma Clinical Trial

— CATALYST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564091
• Other study ID #: NE 03021
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

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