Clinical Trial to Evaluate the Safety and Effectiveness o... | NCT05696561

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

NCT05696561

Sponsor

New World Medical, Inc.

Status

Recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

OAG - Open-Angle Glaucoma

Interventions

Canaloplasty Device

Countries

Chile
Costa Rica
Honduras

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2025Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Jan 13, 2023

First Submission Date that Met QC Criteria

Jan 13, 2023

First Posted Date

Jan 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Feb 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with a Canaloplasty Device	Other	US. FDA Approved Canaloplasty Device	Device: Canaloplasty Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Canaloplasty Device	Device	Canaloplasty	Treatment with a Canaloplasty Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP change	Reduction in unmedicated IOP	Month12

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Swetha Mandava, MS	Contact	9732049467		smandava@newworldmedical.com
Elysia Ison, OD,FAAO	Contact	4083487408		eison@newworldmedical.com

Overall Officials

Name	Affiliation	Role
Mini Balaram, MD	New World Medical, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro de la Vision	Recruiting	Santiago			Chile

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided