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Recruiting

NCT Number: NCT05696561

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

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

Recruiting

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Key information

Conditions

OAG - Open-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de la Vision, Santiago, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Canaloplasty Device

Device

Canaloplasty

Primary outcomes

  1. IOP change

    Time frame: Month12

    Reduction in unmedicated IOP

Secondary outcomes

  1. IOP

    Time frame: Month12

    Percentage Change in unmedicated IOP

  2. IOP meds

    Time frame: Month12

    Change in number of IOP lowering medications

Study contacts

Contact information is provided by the study sponsor or research team.

Elysia Ison, OD,FAAO

CONTACT

[email protected]

4083487408

Swetha Mandava, MS

CONTACT

[email protected]

9732049467

Sponsors and collaborators

Lead sponsor

New World Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 25, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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