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

PLU Ophthalmic

Status: Not yet enrolling

Conditions: Glaucoma Open-Angle

Treatments: Device: Glaucoma surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT06809647

PLU-01

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

This is the group that will undergo the surgical treatment

Experimental group

Treatment:

Device: Glaucoma surgery