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

Not Applicable

Not yet recruiting

• Conditions: POAG
• Interventions: Device: Canaloplasty Device

• Registration Number: NCT05696561
• Lead 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Study Start: 2024-10
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with a Canaloplasty Device	Canaloplasty Device	Canaloplasty Device

Primary Outcome Measures

Name	Time	Method
IOP change	Month6	proportion of treated eyes with \> 20% change in unmedicated IOP

Secondary Outcome Measures

Name	Time	Method
IOP meds	Month 6 and 12	Change in number of IOP lowering medications
IOP	Months 6 and 12	Change in IOP

Trial Locations

Locations (3)

Centro Oftalmologico Robles; 🇭🇳 Santa Rosa De Copán, Honduras

Laser y Ultrasonido Ocular; 🇲🇽 Puebla, Mexico

Clinica 20/20; 🇨🇷 San José, Costa Rica