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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-reinforced canaloplasty | Participants with OAG who undergo the bio-reinforced canaloplasty procedure to enhance trabecular outflow for achievement/maintenance of target IOP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlloSpan Canal Platform Bio-Reinforced Canaloplasty | Procedure | 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. |
| 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 |
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| 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 |
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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Patients with OAG who are determined to need surgical intervention for maintenance of target IOP
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| Name | Affiliation | Role |
|---|---|---|
| Tsontcho Ianchulev, MD, MPH | Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ridge Eye Care, Inc. | Chico | California | 95928 | United States | ||
| North Bay Eye Associates |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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|
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 |
| Petaluma |
| California |
| 94954 |
| United States |
| Scott & Christie and Associates | Cranberry Township | Pennsylvania | 16066 | United States |
| Key Whitman Eye Center | Dallas | Texas | 75243 | United States |
| El Paso Eye Surgeons | El Paso | Texas | 79922 | United States |