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

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of a canaloplasty device — a minimally invasive tool that opens up the eye's natural drainage canal — in people who have both open-angle glaucoma (a common type of eye pressure problem) and cataracts. **You may be eligible if...** - You qualify for cataract surgery - You have open-angle glaucoma in at least one eye with elevated eye pressure (22–34 mmHg when off eye drops) **You may NOT be eligible if...** - You cannot safely stop your eye pressure–lowering medications for a washout period before measurement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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