Evaluation of Hydrus Microstent after cataract surgery for glaucoma

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

This study is testing how well the Hydrus Microstent works for people with glaucoma after they have cataract surgery to see if it stays in place and improves their eye health over two years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 545 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Alcon Research (Industry-sponsored)
• Locations: 22 sites (Irvine, California and 21 other locations)
• Trial ID: NCT04553523 on ClinicalTrials.gov

What this trial studies

This post-approval study aims to assess the rate of malposition and clinical outcomes associated with the Hydrus Microstent within 24 months following its implantation. Participants will undergo uncomplicated cataract surgery with a monofocal intraocular lens, followed by the placement of the Hydrus Microstent. The study includes a series of scheduled postoperative visits to monitor the subjects' progress and any complications. The research is sponsored by Alcon Research, following their acquisition of Ivantis, Inc.

Who should consider this trial

Good fit: Ideal candidates are individuals with operable cataracts and primary open angle glaucoma who are currently using no more than four topical hypotensive medications.

Not a fit: Patients with closed angle glaucoma, congenital glaucoma, or those who have undergone previous glaucoma surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the management of primary open angle glaucoma by providing insights into the safety and effectiveness of the Hydrus Microstent.

How similar studies have performed: Other studies involving microstent implantation for glaucoma have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
* Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
* Optic nerve appearance characteristic of glaucoma;
* Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Closed angle forms of glaucoma;
* Congenital or developmental glaucoma;
* Secondary glaucoma;
* Use of more than 4 ocular hypotensive medications;
* Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;
* Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;
* Other protocol-defined exclusion criteria may apply.

Where this trial is running

Irvine, California and 21 other locations

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

Study contacts

• Study coordinator: Alcon Call Center

Conditions Primary Open Angle Glaucoma