Hydrus® Microstent New Enrollment Post-Approval Study
Recruiting · NCT04553523 · Interventional (participants receive a specific treatment) · Lead sponsor: Alcon Research
View the official record on ClinicalTrials.gov →Interventions studied
Cataract surgeryHydrus MicrostentMonofocal IOL
What this trial is about
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 take part
Age range
45 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
22 locations listed across 15 US states.
- Coastal Vision - Irvine, California, United States
- Sacramento Eye Consultants - Sacramento, California, United States
- Eye Center of Northern Colorado - Loveland, Colorado, United States
- Jones Eye Center PC - Sioux City, Iowa, United States
- Stiles Eyecare Excellence Cataracts and Glaucoma - Overland Park, Kansas, United States
- Visionary Eye Doctors - Rockville, Maryland, United States
- Fraser Eye Care Center - Fraser, Michigan, United States
- Twin Cities Eye Consultants - Coon Rapids, Minnesota, United States
- Midwest Vision Research Foundation - Chesterfield, Missouri, United States
- Moyes Eye Center - Kansas City, Missouri, United States
- Center for Sight - Las Vegas, Nevada, United States
- Carolina Eye Associates PA - Southern Pines, North Carolina, United States
- Cleveland Eye Clinic - Brecksville, Ohio, United States
- Cincinnati Eye Institute - Cincinnati, Ohio, United States
- Cincinnati Eye / Apex Eye - Mason, Ohio, United States
- Scott & Christie and Associates, PC - Cranberry Township, Pennsylvania, United States
- Texan Eye / Keystone Research - Austin, Texas, United States
- Glaucoma Associates Of Texas - Dallas, Texas, United States
- El Paso Eye Surgeons - El Paso, Texas, United States
- Texas Eye Research Center - Hurst, Texas, United States
- The Eye Institute of Utah - Salt Lake City, Utah, United States
- Eye Centers Of Racine And Kenosha - Kenosha, Wisconsin, United States