An observational study in Open-Angle Glaucoma, sponsored by Iantrek, Inc.. Enrolling by invitation at 9 sites in United States. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Iantrek, Inc. · Observational
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.
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.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 300 is above the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Iantrek, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with OAG who are determined to need surgical intervention for maintenance of target IOP
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 , or non-standard of care procedures and/or treatments ≤ 12 weeks prior to bio-reinforced canaloplasty
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with OAG who undergo canaloplasty followed by intraluminal placement of minimally manipulated, homologous-use scleral allograft tissue within Schlemm's canal lumen.
Procedure: AlloSpan Canal Platform Bio-Reinforced Canaloplasty
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.
Mean change in IOP
Mean change in IOP as compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery
Time frame: 12 months, 24 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 months
Rate of secondary surgical interventions for IOP control
Secondary surgical interventions for IOP control
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Iantrek, Inc.