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

Nova Eye, Inc.

Status: Enrolling

Conditions: Primary Open Angle Glaucoma

Treatments: Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device; Procedure: Cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT05564091

NE 03021

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Cataract surgery combined with ab-interno canaloplasty

Active Comparator group

Description:

Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)

Treatment:

Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device

Control: Cataract surgery

Other group

Description:

Cataract surgery alone

Treatment:

Procedure: Cataract surgery