Clinical Trial

A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent

Active, Not Recruiting
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Summary
The purpose of this research study is to evaluate the safety and effectiveness of the Aquea Intracanalicular Glaucoma Stent in lowering intraocular pressure (IOP) in patients with cataract and open angle glaucoma. The main questions it aims to answer are: * What proportion of eyes will have a ≥ 20% decrease in IOP from the hypotensive medication-free baseline examination to the hypotensive medication-free 12-month postoperative examination. * What is the mean change in IOP between the hypotensive medication-free baseline examination and hypotensive medication-free 12-month postoperative examination. Participants will be screened for eligibility. * Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline for their ocular condition. * Subjects will undergo implantation of the Aquea Intracanalicular Glaucoma Stent in one eye in conjunction with cataract surgery. * Postoperatively, subjects will undergo evaluation at regularly scheduled intervals.
Trial Details
NCT Number NCT07698353
Lead Sponsor Aquea Health, Inc.
Conditions Glaucoma, Open-Angle, Cataract Senile
Enrollment 29 participants
Start Date 2024-04-17
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-13