🏛️ Verified NIH Record • Updated 2026-07-13

Hydrus® Microstent New Enrollment Post-Approval Study (NCT04553523)

The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Alcon Research

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

The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.

Who can join: Review the eligibility criteria below.

Location: Coastal Vision — Irvine, California

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 (22 Sites)

  • Coastal Vision — Irvine, California
  • Sacramento Eye Consultants — Sacramento, California
  • Eye Center of Northern Colorado — Loveland, Colorado
  • Jones Eye Center PC — Sioux City, Iowa
  • Stiles Eyecare Excellence Cataracts and Glaucoma — Overland Park, Kansas
  • Visionary Eye Doctors — Rockville, Maryland
  • Fraser Eye Care Center — Fraser, Michigan
  • Twin Cities Eye Consultants — Coon Rapids, Minnesota
  • Midwest Vision Research Foundation — Chesterfield, Missouri
  • Moyes Eye Center — Kansas City, Missouri
  • Center for Sight — Las Vegas, Nevada
  • Carolina Eye Associates PA — Southern Pines, North Carolina
  • Cleveland Eye Clinic — Brecksville, Ohio
  • Cincinnati Eye Institute — Cincinnati, Ohio
  • Cincinnati Eye / Apex Eye — Mason, Ohio
  • Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania
  • Texan Eye / Keystone Research — Austin, Texas
  • Glaucoma Associates Of Texas — Dallas, Texas
  • El Paso Eye Surgeons — El Paso, Texas
  • Texas Eye Research Center — Hurst, Texas
  • The Eye Institute of Utah — Salt Lake City, Utah
  • Eye Centers Of Racine And Kenosha — Kenosha, Wisconsin

📞 Contact the Study Coordinator

Phone: (888) 451-3937

Email: alcon.medinfo@alcon.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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. Contact the study coordinator using the phone/email above.
  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 ↗