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

February 24, 2026 updated by: New World Medical, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • Centro de la Vision
        • Contact:
          • Edison Villagran
  • Costa Rica
      • San José, Costa Rica
        • Recruiting
        • Clinica 20/20
        • Contact:
          • Nadja Dodero
          • Phone Number: +506 8375-8263
        • Principal Investigator:
          • Claudio Orlich, MD
  • Honduras
      • Santa Rosa de Copán, Honduras
        • Not yet recruiting
        • Centro Oftalmologico Robles
        • Contact:
          • Gricelda Ortiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment with a Canaloplasty Device
US. FDA Approved Canaloplasty Device
Device: Canaloplasty Device
Canaloplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP change
Time Frame: Month12
Reduction in unmedicated IOP
Month12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP
Time Frame: Month12
Percentage Change in unmedicated IOP
Month12
IOP meds
Time Frame: Month12
Change in number of IOP lowering medications
Month12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New World Medical, Inc.

Investigators

  • Study Director: Mini Balaram, MD, New World Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF12-CL-22-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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