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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Open-Angle Glaucoma
• Intervention / Treatment: Procedure: AlloSpan Canal Platform Bio-Reinforced Canaloplasty

Detailed Description

The purpose of this observational study is to evaluate postoperative outcomes in a real-world setting after bio-reinforced canaloplasty for trabecular outflow enhancement in eyes with OAG. Outcomes of interest include change in intraocular pressure (IOP), change in use of glaucoma medications, related adverse events, and surgical reinterventions for additional IOP control.

Patients will be approached for study enrollment based on investigator determination that surgical intervention is necessary to maintain target IOP and the patient may benefit from bio-reinforced canaloplasty.

After surgery, data will be collected from participant examinations on Day 1 and at approximately 1, 3, 6, 12, 18 and 24 months. Examinations at each visit are performed per the investigator's standard of care.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • California
    • Chico, California, United States, 95928
      • Ridge Eye Care, Inc.
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates
  • Texas
    • Dallas, Texas, United States, 75243
      • Key Whitman Eye Center
    • El Paso, Texas, United States, 79922
      • El Paso Eye Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with OAG who are determined to need surgical intervention for maintenance of target IOP

Description

Inclusion Criteria:

1. Diagnosis of OAG in the study eye and a candidate for bio-reinforced canaloplasty for aqueous outflow enhancement, as determined by investigator

Exclusion Criteria:

1. 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

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Bio-reinforced canaloplasty; Participants with OAG who undergo the bio-reinforced canaloplasty procedure to enhance trabecular outflow for achievement/maintenance of target IOP.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eyes with ≥ 20% IOP reduction	Proportion of eyes with ≥ 20% IOP reduction compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery	12 months, 24 months
Proportion of eyes achieving IOP ≥ 20% reduction without glaucoma medication	Proportion of eyes achieving IOP ≥ 20% reduction compared to baseline without use of IOP-lowering medication or IOP-lowering surgery	12 months, 24 months
Mean change in glaucoma medication use	Mean change in IOP-lowering medications compared to baseline in eyes without secondary IOP-lowering surgery	12 months, 24 months
Proportion of eyes with IOP ≥ 6 mmHg and ≤ 18 mmHg	Proportion of eyes with IOP ≥ 6 mmHg and ≤ 18 mmHg without increase in IOP-lowering medications or secondary IOP-lowering surgery	12 months, 24 months
Proportion of eyes with IOP ≥ 6 mmHg and ≤ 18 mmHg without glaucoma medication	Proportion of eyes with IOP ≥ 6 mmHg and ≤ 18 mmHg, without use of IOP-lowering medication or IOP-lowering surgery	12 months, 24 months
Related ocular adverse events	Incidence of ocular adverse events considered possibly, probably, or definitely related to the study product or surgical procedure	24 months
Rate of secondary surgical interventions for IOP control	Secondary surgical interventions for IOP control	24 months

Collaborators and Investigators

• Sponsor: Iantrek, Inc.
• Investigators: Study Chair: Tsontcho Ianchulev, MD, MPH, Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: open-angle glaucoma; bio-reinforced canaloplasty
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: ITR-CAN-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No