Hydrus® Microstent New Enrollment Post-Approval Study (CONFIRM)

Alcon

Status

Enrolling

Conditions

Primary Open Angle Glaucoma

Treatments

Device: Hydrus Microstent

Device: Monofocal IOL

Procedure: Cataract surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT04553523

GLI314-C003 (Other Identifier)

CP 18-001

Details and patient eligibility

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.

Full 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.

Enrollment

545 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.