🏛️ Verified NIH Record • Updated 2026-07-07

A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent (NCT07698353)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Aquea Health, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Panama Eye Center — Panama City, Provincia de Panamá

Age range: 45 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (1 Sites)

  • Panama Eye Center — Panama City, Provincia de Panamá

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗