A Study of Outcomes Following Bio-Reinforced Canaloplasty in Eyes With Open-Angle Glaucoma

NCT07520175 · tracked via the Priya Life Science USA tracker

Sponsor

Iantrek, Inc.

Phase

Observational

Started

2026-04-01

Last updated

2026-07-22

Condition(s) studied

Open-Angle Glaucoma

Investigational drug(s) / intervention(s)

AlloSpan Canal Platform Bio-Reinforced Canaloplasty

AlloSpan Canal Platform Bio-Reinforced Canaloplasty: A canaloplasty procedure is performed using AlloSpan Canal manual surgical instrumentation. After canaloplasty, minimally manipulated, homologous-use scleral allograft tissue is placed within in the canal-wall region of the Schlemm's canal lumen to provide structural reinforcement.

Study summary

The goal of this study is to learn about outcomes after bio-reinforced canaloplasty surgery in patients with OAG. The key question the study aims to answer is:

How much does the surgical procedure lower pressure inside the eye and what is the durability of this effect?

Participants will return for periodic eye exams for 2 years following surgery.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1\. Diagnosis of OAG in the study eye and a candidate for bio-reinforced canaloplasty for aqueous outflow enhancement, as determined by investigator Exclusion Criteria: 1\. Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, or neovascular glaucoma in the study eye 2. Previous minimally invasive or filtering glaucoma surgery in the study eye 3. Previous IOP-lowering procedure ≤ 12 weeks prior to bio-reinforced canaloplasty in the study eye 5. Previous investigational, or non-standard of care procedures and/or treatments ≤ 12 weeks prior to bio-reinforced canaloplasty \-

Primary outcome measure(s)

Mean change in IOP — 12 months, 24 months
Mean change in IOP as compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery

Trial sites (7)

Facility	City	Region
North Valley Eye Care	Chico	California
North Bay Eye Associates	Petaluma	California
Twin Cities Eye Consultants	Coon Rapids	Minnesota
Cataract & Laser Institute	Medford	Oregon
Scott & Christie Eyecare Associates	Cranberry Township	Pennsylvania
Key-Whitman Eye Center	Dallas	Texas
El Paso Eye Surgeons	El Paso	Texas

More Iantrek, Inc. trials in the USA

Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes Active, not recruiting

A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma Active, not recruiting

5-Year Postoperative Outcomes of Patients Who Completed the CREST Study Enrolling by invitation

Other trials for the same condition

AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07520175 on ClinicalTrials.gov ↗ ← All trials in the USA