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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05696561
Enrollment
70
Registered
2023-01-25
Start date
2025-09-09
Completion date
2027-10-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OAG - Open-Angle Glaucoma

Brief summary

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

Interventions

DEVICECanaloplasty Device

Canaloplasty

Sponsors

New World Medical, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
IOP changeMonth12Reduction in unmedicated IOP

Secondary

MeasureTime frameDescription
IOPMonth12Percentage Change in unmedicated IOP
IOP medsMonth12Change in number of IOP lowering medications

Countries

Chile, Costa Rica, Honduras

Contacts

CONTACTSwetha Mandava, MS
smandava@newworldmedical.com9732049467
CONTACTElysia Ison, OD,FAAO
eison@newworldmedical.com4083487408
STUDY_DIRECTORMini Balaram, MD

New World Medical, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026