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 — 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Bio-reinforced canaloplasty
    Participants with OAG who undergo the bio-reinforced canaloplasty procedure to enhance trabecular outflow for achievement/maintenance of target IOP.

Primary Outcome Measure

Mean change in IOP [ Time Frame: 12 months, 24 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Ridge Eye Care, Inc.ChicoCalifornia95928-
North Bay Eye AssociatesPetalumaCalifornia94954-
Scott & Christie and AssociatesCranberry TownshipPennsylvania16066-
Key Whitman Eye CenterDallasTexas75243-
El Paso Eye SurgeonsEl PasoTexas79922-

Find similar trials in Chico, CA

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Ridge Eye Care, Inc.· Chico, CANorth Bay Eye Associates· Petaluma, CAScott & Christie and Associates· Cranberry Township, PAKey Whitman Eye Center· Dallas, TXEl Paso Eye Surgeons· El Paso, TX

Related Studies