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

NCT ID: NCT05696561

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

POAG

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment with a Canaloplasty Device

Canaloplasty Device

Group Type EXPERIMENTAL

Canaloplasty Device

Intervention Type DEVICE

Canaloplasty

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Canaloplasty Device

Canaloplasty

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

New World Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark Sun, PhD

Role: STUDY_DIRECTOR

New World Medical, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinica 20/20

San José, , Costa Rica

Site Status

Centro Oftalmologico Robles

Santa Rosa de Copán, , Honduras

Site Status

Laser y Ultrasonido Ocular

Puebla City, , Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Costa Rica Honduras Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Heather P Reynolds, MS

Role: CONTACT

8176881689

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DF12-CL-22-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Canadian Glaucoma Study
NCT00262626 TERMINATED NA