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

NCT07520175 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Open-Angle Glaucoma

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.

Sponsors & Collaborators

  • Iantrek, Inc.

    lead INDUSTRY

Principal Investigators

  • Tsontcho Ianchulev, MD, MPH · Chief Medical Officer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07520175 on ClinicalTrials.gov