A Study of Outcomes Following Bio-Reinforced Canaloplasty in Eyes With Open-Angle Glaucoma
BOOST
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)
1 other identifier
observational
300
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
July 22, 2026
July 1, 2026
2.7 years
March 31, 2026
July 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in IOP
Mean change in IOP as compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery
12 months, 24 months
Other Outcomes (7)
Proportion of eyes with ≥ 20% IOP reduction
12 months, 24 months
Proportion of eyes achieving IOP ≥ 20% reduction without glaucoma medication
12 months, 24 months
Mean change in glaucoma medication use
12 months, 24 months
- +4 more other outcomes
Study Arms (1)
Bio-reinforced canaloplasty
Participants with OAG who undergo canaloplasty followed by intraluminal placement of minimally manipulated, homologous-use scleral allograft tissue within Schlemm's canal lumen.
Interventions
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 Criteria
Patients with OAG who are determined to need surgical intervention for maintenance of target IOP
You 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Iantrek, Inc.lead
Study Sites (7)
North Valley Eye Care
Chico, California, 95928, United States
North Bay Eye Associates
Petaluma, California, 94954, United States
Twin Cities Eye Consultants
Coon Rapids, Minnesota, 55433, United States
Cataract & Laser Institute
Medford, Oregon, 97504, United States
Scott & Christie Eyecare Associates
Cranberry Township, Pennsylvania, 16066, United States
Key-Whitman Eye Center
Dallas, Texas, 75243, United States
El Paso Eye Surgeons
El Paso, Texas, 79922, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tsontcho Ianchulev, MD, MPH
Chief Medical Officer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2026
First Posted
April 9, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share