The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Coastal Vision
COMPLETED
Irvine
Sacramento Eye Consultants
RECRUITING
Sacramento
Colorado
Eye Center of Northern Colorado
RECRUITING
Loveland
Iowa
Jones Eye Center PC
RECRUITING
Sioux City
Kansas
Stiles Eyecare Excellence Cataracts and Glaucoma
NOT_YET_RECRUITING
Overland Park
Maryland
Visionary Eye Doctors
NOT_YET_RECRUITING
Rockville
Michigan
Fraser Eye Care Center
RECRUITING
Fraser
Minnesota
Twin Cities Eye Consultants
RECRUITING
Coon Rapids
Missouri
Midwest Vision Research Foundation
RECRUITING
Chesterfield
Moyes Eye Center
NOT_YET_RECRUITING
Kansas City
North Carolina
Carolina Eye Associates PA
RECRUITING
Southern Pines
Nevada
Center for Sight
RECRUITING
Las Vegas
Ohio
Cleveland Eye Clinic
COMPLETED
Brecksville
Cincinnati Eye Institute
RECRUITING
Cincinnati
Cincinnati Eye / Apex Eye
NOT_YET_RECRUITING
Mason
Pennsylvania
Scott & Christie and Associates, PC
NOT_YET_RECRUITING
Cranberry Township
Texas
Texan Eye / Keystone Research
RECRUITING
Austin
Glaucoma Associates Of Texas
NOT_YET_RECRUITING
Dallas
El Paso Eye Surgeons
RECRUITING
El Paso
Texas Eye Research Center
RECRUITING
Hurst
Utah
The Eye Institute of Utah
NOT_YET_RECRUITING
Salt Lake City
Wisconsin
Eye Centers Of Racine And Kenosha
RECRUITING
Kenosha
Contact Information
Primary
Alcon Call Center
alcon.medinfo@alcon.com
1-888-451-3937
Time Frame
Start Date: 2020-08-25
Estimated Completion Date: 2028-06
Participants
Target number of participants: 545
Treatments
Experimental: Hydrus Microstent
Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)
Related Therapeutic Areas
Sponsors
Leads: Alcon Research