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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

ConditionGlaucoma Open-Angle
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPLU Ophthalmic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Moderate to severe open angle glaucoma

Central corneal thickness between 480 and 610 microns

Disqualifiers

surgical history of corneal graft

presence of corneal opacities

Failed prior trabeculectomy

Trial design

Design model

Single group

Treatments tested in this trial

  • Glaucoma surgery

    Device

    This is an implant-free, minimally invasive glaucoma surgery

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: This is the group that will undergo the surgical treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intra Ocular pressure

Time frame
12 months
2

Use of concomitant topical glaucoma medications

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PLU Ophthalmic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: