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Hydrus Microstent for Refractory Open-Angle Glaucoma

NCT03267134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2026-01-14

Study results available
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Summary

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.

Conditions

  • Open-angle Glaucoma

Interventions

DEVICE

Hydrus Microstent

Device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.

PROCEDURE

Ophthalmic surgery

Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia

Sponsors & Collaborators

  • Ivantis, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Project Lead, CRD Surgical · Alcon Research, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-12-16
Completion
2022-12-16
FDA Device
Yes

Countries

  • United States
  • Colombia
  • Philippines
  • Spain
  • United Kingdom

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 NCT03267134 on ClinicalTrials.gov