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.
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
- Are there results?
- Not yet: the study is under way
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
- -
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
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
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 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.
- 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
Sponsor and investigators
- Lead sponsor
- Iantrek, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsontcho Ianchulev, MD, MPH, Study chair, Chief Medical Officer
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07520175
- Acronym / sponsor ID
- BOOST / ITR-CAN-041
- Conditions
- Open-Angle Glaucoma
- Keywords
- bio-reinforced canaloplasty, open-angle glaucoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Iantrek, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bio-reinforced canaloplasty | – | Procedure: AlloSpan Canal Platform Bio-Reinforced CanaloplastyParticipants with OAG who undergo canaloplasty followed by intraluminal placement of minimally manipulated, homologous-use scleral allograft tissue within Schlemm's canal lumen. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with OAG who are determined to need surgical intervention for maintenance of target IOP
Key inclusion criteria (1 listed)
- 1. Diagnosis of OAG in the study eye and a candidate for bio-reinforced canaloplasty for aqueous outflow enhancement, as determined by investigator
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlloSpan Canal Platform Bio-Reinforced CanaloplastyA 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. | Procedure or surgery | Bio-reinforced canaloplasty |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsontcho Ianchulev, MD, MPH study chair
Chief Medical Officer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open-Angle Glaucoma, run by Iantrek, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in IOP (time frame: 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.