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ENROLLING BY INVITATION
NCT07520175

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

Sponsor: Iantrek, Inc.

View on ClinicalTrials.gov

Summary

The goal of this study is to learn about outcomes after bio-reinforced canaloplasty surgery to enhance aqueous outflow 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.

Official title: An Observational Study of Safety and Effectiveness Outcomes Following Bio-Reinforced Canaloplasty for Trabecular Outflow Enhancement in Eyes With Open-Angle Glaucoma (The BOOST Study)

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-04-01

Completion Date

2029-12

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

PROCEDURE

AlloSpan Canal Platform Bio-Reinforced Canaloplasty

Bio-reinforced canaloplasty using the AlloSpan Canal Platform is a gonio-interventional approach to enhance trabecular outflow. Standard gonio-positioning of the microscope and the head is involved. A clear corneal incision is performed temporally. The anterior chamber is filled with viscoelastic and the angle is expanded and visualized to identify the gonio-structures. An entry gonio-puncture of the trabecular meshwork is performed to enter the canal and canaloplasty is performed with intraluminal dilation. After canaloplasty, a segmental canal scaffolding implant consisting of allograft scleral tissue is deployed for sustained canal reinforcement and dilation.

Locations (1)

El Paso Eye Surgeons

El Paso, Texas, United States