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OpenTrials
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NCT Number: NCT06809647

A Prospective Interventional Cohort Study to Evaluate the Efficacy and Safety of the AquaLumen, a Novel Filtration Procedure for the Treatment of Open Angle Glaucoma

The study will follow a group of patients with glaucoma disease that undergo a surgical procedure intended to reduce the intra-ocular pressure (IOP) for a period of one year.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe open angle glaucoma
  • Central corneal thickness between 480 and 610 microns

Exclusion criteria

  • surgical history of corneal graft
  • presence of corneal opacities
  • Failed prior trabeculectomy

Treatment and study plan

Glaucoma surgery

Device

This is an implant-free, minimally invasive glaucoma surgery

Primary outcomes

  1. Intra Ocular pressure

    Time frame: 12 months

  2. Use of concomitant topical glaucoma medications

    Time frame: 12 months

Study contacts

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

Carlos A Urrea, MD

CONTACT

[email protected]

215-327-5500

Sponsors and collaborators

Lead sponsor

PLU Ophthalmic

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

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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