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NCT05696561 | Not yet recruiting | POAG


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

New World Medical, Inc.

Brief Summary:

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

Condition or disease

POAG

Intervention/treatment

Canaloplasty Device

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : July 2025
Arm Intervention/treatment

Experimental: Treatment with a Canaloplasty Device

Canaloplasty Device

Device: Canaloplasty Device

Ages Eligible for Study: 22 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Subjects qualifying for cataract surgery
  • 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.

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Costa Rica,

Clinica 20/20

San José, Costa Rica,

Not yet recruiting

Honduras,

Centro Oftalmologico Robles

Santa Rosa De Copán, Honduras,

Not yet recruiting

Mexico,

Laser y Ultrasonido Ocular

Puebla, Mexico,

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