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Hydrus® Microstent New Enrollment Post-Approval Study

NCT04553523 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 545

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

  • Primary Open Angle Glaucoma

Interventions

DEVICE

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.

PROCEDURE

Cataract surgery

Cataract surgery performed using standard anesthesia and phacoemulsification techniques

DEVICE

Monofocal IOL

Commercially available monofocal intraocular lens as determined by the investigator

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Project Lead, CDMA Surgical · Alcon Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553523 on ClinicalTrials.gov