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

N/AEnrolling By InvitationNCT07520175

Iantrek, Inc.300 enrolled

Overview

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.

The purpose of this observational study is to evaluate postoperative outcomes in a real-world setting after bio-reinforced canaloplasty in eyes with OAG. Outcomes of interest include change in intraocular pressure (IOP), change in use of glaucoma medications, related adverse events, and surgical reinterventions for additional IOP control. Patients will be approached for study enrollment based on investigator determination that surgical intervention is necessary to maintain target IOP and the patient may benefit from bio-reinforced canaloplasty. After surgery, data will be collected from participant examinations on Day 1 and at approximately 1, 3, 6, 12, 18 and 24 months. Examinations at each visit are performed per the investigator's standard of care.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Open-Angle Glaucoma

Interventions

AlloSpan Canal Platform Bio-Reinforced CanaloplastyPROCEDURE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 \-

Locations (7)

North Valley Eye Care

Chico, California, United States

North Bay Eye Associates

Petaluma, California, United States

Twin Cities Eye Consultants

Coon Rapids, Minnesota, United States

Cataract & Laser Institute

Medford, Oregon, United States

Outcomes

Primary Outcomes

Mean change in IOP

Mean change in IOP as compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery

Time frame: 12 months, 24 months

Data from ClinicalTrials.gov

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