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A Study of Outcomes Following Bio-Reinforced Canaloplasty in Eyes With Open-Angle Glaucoma
Sponsor: Iantrek, Inc.
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
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
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 (5)
Ridge Eye Care, Inc.
Chico, California, United States
North Bay Eye Associates
Petaluma, California, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, United States
Key Whitman Eye Center
Dallas, Texas, United States
El Paso Eye Surgeons
El Paso, Texas, United States