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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05564091

Acronym

CATALYST

Enrollment

Registered

2022-10-03

Start date

2022-09-08

Completion date

2027-07-31

Last updated

2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma

Keywords

Canaloplasty

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 24 months.

Interventions

DEVICECataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device

360 degree microcatheterization and viscodilation of Schlemm's canal

PROCEDURECataract surgery

Cataract surgery alone

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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) * Prior goniotomy, or trabeculotomy (ab-interno or ab-externo) * Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject) * 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

Design outcomes

Primary

Measure	Time frame	Description
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
Reduction in number of glaucoma medications at 12 months compared to baseline	12 months	The number of glaucoma medications will be recorded at 12 months compared to baseline

Secondary

Measure	Time frame	Description
Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline	24 months	IOP will be measured at each study visit using Goldmann applanation tonometry
Reduction in glaucoma medications at 24-months compared to baseline	24 months	The number of glaucoma medications will be recorded at 24-months compared to baseline

Countries

Germany, United States

Contacts

Primary ContactMike Pickrel

MPickrel@Nova-Eye.com800-391-2316

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026