NCT04553523Recruiting
Hydrus® Microstent New Enrollment Post-Approval Study
The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 545 (estimated)
- First submitted
- 11 Sept 2020
- Start date
- 25 Aug 2020
- Primary completion date
- Oct 2028
- Lead sponsor
- Alcon Research
- Diseases
- Glaucoma
- NCT number
- NCT04553523
What you commit to
- Study type: Interventional
- Planned participants: 545
- From 25 Aug 2020 to the primary completion date, Oct 2028
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Closed angle forms of glaucoma;
- Congenital or developmental glaucoma;
- Secondary glaucoma;
- Other protocol-defined exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texan Eye / Keystone Research Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Cleveland Eye Clinic Coordinator of this site? Confirm its status | Brecksville | United States | Completed |
| Midwest Vision Research Foundation Coordinator of this site? Confirm its status | Chesterfield | United States | Recruiting |
| Cincinnati Eye Institute Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Twin Cities Eye Consultants Coordinator of this site? Confirm its status | Coon Rapids | United States | Recruiting |
| Scott & Christie and Associates, PC Coordinator of this site? Confirm its status | Cranberry Township | United States | Not yet recruiting |
| Glaucoma Associates of Texas Coordinator of this site? Confirm its status | Dallas | United States | Not yet recruiting |
| El Paso Eye Surgeons Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| Fraser Eye Care Center Coordinator of this site? Confirm its status | Fraser | United States | Recruiting |
| Texas Eye Research Center Coordinator of this site? Confirm its status | Hurst | United States | Recruiting |
| Coastal Vision Coordinator of this site? Confirm its status | Irvine | United States | Completed |
| Moyes Eye Center Coordinator of this site? Confirm its status | Kansas City | United States | Not yet recruiting |
| Eye Centers of Racine and Kenosha Coordinator of this site? Confirm its status | Kenosha | United States | Recruiting |
| Center for Sight Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Eye Center of Northern Colorado Coordinator of this site? Confirm its status | Loveland | United States | Recruiting |
| Cincinnati Eye / Apex Eye Coordinator of this site? Confirm its status | Mason | United States | Not yet recruiting |
| Stiles Eyecare Excellence Cataracts and Glaucoma Coordinator of this site? Confirm its status | Overland Park | United States | Not yet recruiting |
| Visionary Eye Doctors Coordinator of this site? Confirm its status | Rockville | United States | Not yet recruiting |
| Sacramento Eye Consultants Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| The Eye Institute of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Not yet recruiting |
| Jones Eye Center PC Coordinator of this site? Confirm its status | Sioux City | United States | Recruiting |
| Carolina Eye Associates PA Coordinator of this site? Confirm its status | Southern Pines | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.