Hydrus® Microstent New Enrollment Post-Approval Study

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.

Conditions

Primary Open Angle Glaucoma

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Hydrus® Microstent New Enrollment Post-Approval Study

Condition
Primary Open Angle Glaucoma
Intervention / Treatment

-

Contacts and Locations

Irvine

Coastal Vision, Irvine, California, United States, 92618

Sacramento

Sacramento Eye Consultants, Sacramento, California, United States, 95815

Loveland

Eye Center of Northern Colorado, Loveland, Colorado, United States, 80538

Sioux City

Jones Eye Center PC, Sioux City, Iowa, United States, 51104

Overland Park

Stiles Eyecare Excellence Cataracts and Glaucoma, Overland Park, Kansas, United States, 66213

Rockville

Visionary Eye Doctors, Rockville, Maryland, United States, 20852

Fraser

Fraser Eye Care Center, Fraser, Michigan, United States, 48026

Coon Rapids

Twin Cities Eye Consultants, Coon Rapids, Minnesota, United States, 55433

Chesterfield

Midwest Vision Research Foundation, Chesterfield, Missouri, United States, 63017

Kansas City

Moyes Eye Center, Kansas City, Missouri, United States, 64154

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alcon Research,

Clinical Project Lead, CDMA Surgical, STUDY_DIRECTOR, Alcon Research

Study Record Dates

2028-06