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

NCT07698353 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • Glaucoma, Open-Angle
  • Cataract Senile

Interventions

DEVICE

Aquea Zealix™

The Zealix stent is a helical shaped stent with variable pitch across the length of the implant specifically designed to keep Schlemm's canal adequately dilated to its natural healthy diameter. The stent has been designed to reduce IOP by restoring the conventional outflow pathway for aqueous humor, specifically Schlemm's canal (SC). Additionally, the Aquea Zealix stent is also designed to provide a by-pass for the aqueous humor fluid to enter Schlemm's canal and flow unobstructed to access the collector channels for drainage.

Sponsors & Collaborators

  • Aquea Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Lautaro Vera, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-17
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • Panama

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698353 on ClinicalTrials.gov