Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma

New World Medical

Status: Enrolling

Conditions: OAG - Open-Angle Glaucoma

Treatments: Device: Canaloplasty Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05696561

DF12-CL-22-01

Details and patient eligibility

About

Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma

Enrollment: 70 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects qualifying for cataract surgery
2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.

Exclusion criteria

1. Patients who cannot be washed-out of IOP-lowering medications.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Treatment with a Canaloplasty Device

Other group

Description:

US. FDA Approved Canaloplasty Device

Treatment:

Device: Canaloplasty Device