What this study is
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.
What's being tested
- AlloSpan Canal Platform Bio-Reinforced Canaloplasty
Intervention · PROCEDURE
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 details
- 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)
- Sponsor
- Iantrek, Inc.
- Conditions
- Open-Angle Glaucoma
- Enrolling
- 300 people
- Starts
- 2026-04-01
- Est. completion
- 2029-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of OAG in the study eye and a candidate for bio-reinforced canaloplasty for aqueous outflow enhancement, as determined by investigator
You can't join if
- 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 -
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openNorth Valley Eye Care
Chico, California, United States
North Bay Eye Associates
Petaluma, California, United States
Vance Thompson Vision
Alexandria, Minnesota, United States
Twin Cities Eye Consultants
Coon Rapids, Minnesota, United States
Ross Eye Institute
Buffalo, New York, United States
Cataract & Laser Institute
Medford, Oregon, United States
Scott & Christie Eyecare Associates
Cranberry Township, Pennsylvania, United States
Key-Whitman Eye Center
Dallas, Texas, United States
El Paso Eye Surgeons
El Paso, Texas, United States
Study team
Sponsor
Iantrek, Inc.
Study ID ITR-CAN-041
Study chair
Tsontcho Ianchulev, MD, MPH
Chief Medical Officer
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.