A Study of Outcomes Following Bio-Reinforced Canaloplasty in Eyes With Open-Angle Glaucoma
Part of paid clinical trials in Chico, California.
- Sponsor
- Iantrek, Inc.
- Study ID
- NCT07520175
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AlloSpan Canal Platform Bio-Reinforced Canaloplasty — PROCEDUREA 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 Details
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.
Key Dates
- First listed
- Apr 9, 2026
- Start date
- Apr 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 300 participants (estimated)
Arms
- Arm: 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.
Primary Outcome Measure
Mean change in IOP [ Time Frame: 12 months, 24 months ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Valley Eye Care | Chico | California | 95928 | - |
| North Bay Eye Associates | Petaluma | California | 94954 | - |
| Twin Cities Eye Consultants | Coon Rapids | Minnesota | 55433 | - |
| Cataract & Laser Institute | Medford | Oregon | 97504 | - |
| Scott & Christie Eyecare Associates | Cranberry Township | Pennsylvania | 16066 | - |
| Key-Whitman Eye Center | Dallas | Texas | 75243 | - |
| El Paso Eye Surgeons | El Paso | Texas | 79922 | - |
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