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

Primary Purpose

POAG

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Canaloplasty Device
Sponsored by
New World Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for POAG

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects qualifying for cataract surgery 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.

Sites / Locations

  • Clinica 20/20
  • Centro Oftalmologico Robles
  • Laser y Ultrasonido Ocular

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with a Canaloplasty Device

Arm Description

Canaloplasty Device

Outcomes

Primary Outcome Measures

IOP change
proportion of treated eyes with > 20% change in unmedicated IOP

Secondary Outcome Measures

IOP
Change in IOP
IOP meds
Change in number of IOP lowering medications

Full Information

First Posted
January 13, 2023
Last Updated
September 12, 2023
Sponsor
New World Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05696561
Brief Title
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
Official Title
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New World Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
POAG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with a Canaloplasty Device
Arm Type
Experimental
Arm Description
Canaloplasty Device
Intervention Type
Device
Intervention Name(s)
Canaloplasty Device
Intervention Description
Canaloplasty
Primary Outcome Measure Information:
Title
IOP change
Description
proportion of treated eyes with > 20% change in unmedicated IOP
Time Frame
Month6
Secondary Outcome Measure Information:
Title
IOP
Description
Change in IOP
Time Frame
Months 6 and 12
Title
IOP meds
Description
Change in number of IOP lowering medications
Time Frame
Month 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects qualifying for cataract surgery 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather P Reynolds, MS
Phone
8176881689
Email
hreynolds@newworldmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sun, PhD
Organizational Affiliation
New World Medical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinica 20/20
City
San José
Country
Costa Rica
Facility Name
Centro Oftalmologico Robles
City
Santa Rosa De Copán
Country
Honduras
Facility Name
Laser y Ultrasonido Ocular
City
Puebla
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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