RECRUITINGINTERVENTIONAL
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery
About This Trial
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
1\. Patients who cannot be washed-out of IOP-lowering medications.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
Canaloplasty Device
Canaloplasty
Locations (3)
Centro de la Vision
Santiago, Chile
Clínica 20/20
San José, Costa Rica
Centro Oftalmologico Robles
Santa Rosa de Copán, Honduras