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Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

NCT02024464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2024-07-03

Study results available
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Summary

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.

Conditions

  • Primary Open Angle Glaucoma
  • Pseudoexfoliative Glaucoma
  • Pigmentary Dispersion Glaucoma

Interventions

DEVICE

Hydrus Microstent

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

DEVICE

iStent Trabecular Micro Bypass

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

PROCEDURE

Cataract removal and intraocular lens (IOL) implantation

Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects

Sponsors & Collaborators

  • Ivantis, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2017-03-31
Completion
2018-08-31

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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 NCT02024464 on ClinicalTrials.gov