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

Not Applicable

Not yet recruiting

• Conditions: Glaucoma Open-Angle

• Registration Number: NCT06809647
• Lead Sponsor: PLU Ophthalmic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Study Start: 2025-03-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intra Ocular pressure	12 months
Use of concomitant topical glaucoma medications	12 months

Trial Locations

Locations (1)

MUSC Storm Eye Institute; 🇺🇸 Charleston, South Carolina, United States