Open-Angle GlaucomaBOOSTNCT07520175

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

An observational study of Open-Angle Glaucoma, run by Iantrek, Inc. at 9 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Open-Angle Glaucoma
What is being tested?: AlloSpan Canal Platform Bio-Reinforced Canaloplasty
Type of treatment: Surgery or procedure
How many people: 300 participants
Where: 9 sitesUnited States
Study dates: 1 Apr 2026to Dec 2029
How long will I take part?: 24 Months
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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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Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Vance Thompson Vision
Alexandria, Minnesota, 56308
Ross Eye Institute
Buffalo, New York, 14209
North Valley Eye Care
Chico, California, 95928
Twin Cities Eye Consultants
Coon Rapids, Minnesota, 55433
Scott & Christie Eyecare Associates
Cranberry Township, Pennsylvania, 16066
Key-Whitman Eye Center
Dallas, Texas, 75243
El Paso Eye Surgeons
El Paso, Texas, 79922
Cataract & Laser Institute
Medford, Oregon, 97504
North Bay Eye Associates
Petaluma, California, 94954

Other trials in United States

About this study

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)

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.

Read the detailed description

The purpose of this observational study is to evaluate postoperative outcomes in a real-world setting after bio-reinforced canaloplasty 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.

Conditions: Open-Angle Glaucoma
Being tested: AlloSpan Canal Platform Bio-Reinforced Canaloplasty
Keywords: bio-reinforced canaloplasty, open-angle glaucoma
Medical subject headings: Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlloSpan Canal Platform Bio-Reinforced CanaloplastyProcedure or surgery
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 groups in NCT07520175
Study group	Role	What they receive
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. Receives: Procedure: AlloSpan Canal Platform Bio-Reinforced Canaloplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change in IOP
Mean change in IOP as compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery
Measured: 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 2026Dec 2029

First posted9 Apr 2026
Study start1 Apr 2026
Primary completionDec 2028 (estimated)
Study completionDec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 300 participants (estimated)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT07520175
Sponsor's protocol ID: ITR-CAN-041
Acronym: BOOST
Status last verified: Oct 2026
First submitted: 31 Mar 2026
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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