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Enrolling by Invitation

NCT Number: NCT07520175

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

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.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

North Valley Eye Care, Chico, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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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Treatment and study plan

AlloSpan Canal Platform Bio-Reinforced Canaloplasty

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.

Primary outcomes

  1. Mean change in IOP

    Time frame: 12 months, 24 months

    Mean change in IOP as compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery

Other outcomes

  1. Proportion of eyes with ≥ 20% IOP reduction

    Time frame: 12 months, 24 months

    Proportion of eyes with ≥ 20% IOP reduction compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery

  2. Proportion of eyes achieving IOP ≥ 20% reduction without glaucoma medication

    Time frame: 12 months, 24 months

    Proportion of eyes achieving IOP ≥ 20% reduction compared to baseline without use of IOP-lowering medication or IOP-lowering surgery

  3. Mean change in glaucoma medication use

    Time frame: 12 months, 24 months

    Mean change in IOP-lowering medications compared to baseline in eyes without secondary IOP-lowering surgery

  4. Proportion of eyes with IOP ≥ 6 mmHg and ≤ 18 mmHg

    Time frame: 12 months, 24 months

    Proportion of eyes with IOP ≥ 6 mmHg and ≤ 18 mmHg without increase in IOP-lowering medications or secondary IOP-lowering surgery

  5. Proportion of eyes with IOP ≥ 6 mmHg and ≤ 18 mmHg without glaucoma medication

    Time frame: 12 months, 24 months

    Proportion of eyes with IOP ≥ 6 mmHg and ≤ 18 mmHg, without use of IOP-lowering medication or IOP-lowering surgery

  6. Related ocular adverse events

    Time frame: 24 months

    Incidence of ocular adverse events considered possibly, probably, or definitely related to the study product or surgical procedure

  7. Rate of secondary surgical interventions for IOP control

    Time frame: 24 months

    Secondary surgical interventions for IOP control

Sponsors and collaborators

Lead sponsor

Iantrek, Inc.

Industry

Registry information

Official study 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)

Acronym: BOOST

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 9, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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