NCT05696561

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Sep 2025Oct 2027

First Submitted

Initial submission to the registry

January 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
2.6 years until next milestone

Study Start

First participant enrolled

September 9, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 13, 2023

Last Update Submit

February 24, 2026

Conditions

OAG - Open-Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • IOP change

    Reduction in unmedicated IOP

    Month12

Secondary Outcomes (2)

  • IOP

    Month12

  • IOP meds

    Month12

Study Arms (1)

Treatment with a Canaloplasty Device

OTHER

US. FDA Approved Canaloplasty Device

Device: Canaloplasty Device

Interventions

Canaloplasty DeviceDEVICE

Canaloplasty

Treatment with a Canaloplasty Device

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects qualifying for cataract surgery
  • Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centro de la Vision

Santiago, Chile

RECRUITING

Clínica 20/20

San José, Costa Rica

RECRUITING

Centro Oftalmologico Robles

Santa Rosa de Copán, Honduras

NOT YET RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Mini Balaram, MD

    New World Medical, Inc.

    STUDY DIRECTOR

Central Study Contacts

Swetha Mandava, MS

CONTACT

9732049467smandava@newworldmedical.com

Elysia Ison, OD,FAAO

CONTACT

4083487408eison@newworldmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 25, 2023

Study Start

September 9, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)CL(1)HO(1)