Hydrus® Microstent New Enrollment Post-Approval Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

545 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydrus Microstent

Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)

Group Type EXPERIMENTAL

Hydrus Microstent

Intervention Type DEVICE

Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL.

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery performed using standard anesthesia and phacoemulsification techniques

Monofocal IOL

Intervention Type DEVICE

Commercially available monofocal intraocular lens as determined by the investigator

Interventions

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Hydrus Microstent

Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL.

Intervention Type DEVICE

Cataract surgery

Cataract surgery performed using standard anesthesia and phacoemulsification techniques

Intervention Type PROCEDURE

Monofocal IOL

Commercially available monofocal intraocular lens as determined by the investigator

Intervention Type DEVICE

Eligibility Criteria

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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;

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;

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No