RecruitingNot ApplicableNCT05696561

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


Sponsor

New World Medical, Inc.

Enrollment

70 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 22 Years

Inclusion Criteria2

  • 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 Criteria1

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

Interventions

DEVICECanaloplasty 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

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NCT05696561


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