Hydrus® Microstent New Enrollment Post-Approval Study
Start Date
8/25/2020
Completion Date
8/1/2028
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.
Detailed Description
Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
Eligibility Criteria
Age Range: 45 years to No maximum
Interventions
Hydrus Microstent
Cataract surgery
Monofocal IOL
Conditions
Locations
Coastal Vision
Irvine, California 92618
United States
Sacramento Eye Consultants
Sacramento, California 95815
United States
Eye Center of Northern Colorado
Loveland, Colorado 80538
United States
Jones Eye Center PC
Sioux City, Iowa 51104
United States
Stiles Eyecare Excellence Cataracts and Glaucoma
Overland Park, Kansas 66213
United States
Visionary Eye Doctors
Rockville, Maryland 20852
United States
Fraser Eye Care Center
Fraser, Michigan 48026
United States
Twin Cities Eye Consultants
Coon Rapids, Minnesota 55433
United States
Midwest Vision Research Foundation
Chesterfield, Missouri 63017
United States
Moyes Eye Center
Kansas City, Missouri 64154
United States
Center for Sight
Las Vegas, Nevada 89145
United States
Carolina Eye Associates PA
Southern Pines, North Carolina 28387
United States
Cleveland Eye Clinic
Brecksville, Ohio 44141
United States
Cincinnati Eye Institute
Cincinnati, Ohio 45242
United States
Cincinnati Eye / Apex Eye
Mason, Ohio 45040
United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania 16066
United States
Texan Eye / Keystone Research
Austin, Texas 78731
United States
Glaucoma Associates Of Texas
Dallas, Texas 75231
United States
El Paso Eye Surgeons
El Paso, Texas 79902
United States
Texas Eye Research Center
Hurst, Texas 76054
United States
The Eye Institute of Utah
Salt Lake City, Utah 84107
United States
Eye Centers Of Racine And Kenosha
Kenosha, Wisconsin 53142
United States