RECRUITING

Hydrus® Microstent New Enrollment Post-Approval Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-08-25
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04553523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
  2. * Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
  3. * Optic nerve appearance characteristic of glaucoma;
  4. * Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.
  1. * Closed angle forms of glaucoma;
  2. * Congenital or developmental glaucoma;
  3. * Secondary glaucoma;
  4. * Use of more than 4 ocular hypotensive medications;
  5. * Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;
  6. * Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;
  7. * Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Study Contact

Alcon Call Center
CONTACT
1-888-451-3937
alcon.medinfo@alcon.com

Principal Investigator

Clinical Project Lead, CDMA Surgical
STUDY_DIRECTOR
Alcon Research

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Alcon Research

  • Clinical Project Lead, CDMA Surgical, STUDY_DIRECTOR, Alcon Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-25
Study Completion Date2028-06

Study Record Updates

Study Start Date2020-08-25
Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

  • Primary Open Angle Glaucoma