CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 306 enrolled
Drug / intervention
Hydrus Microstent +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02024464
NCT02024464N/ACompleted
CompareCT.gov

A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

Ivantis, Inc.·interventional·Posted Dec 31, 2013·Updated Jul 3, 2024

In Brief

A clinical study evaluating Hydrus Microstent, iStent Trabecular Micro Bypass, and 1 other intervention for Primary Open Angle Glaucoma and 2 related conditions. Completed, enrolled 306 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Dispersion Glaucoma
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2013
Enrollment StartAug 1, 2011
Primary CompletionMar 1, 2017
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 12.5 years ago

Interventions

Hydrus Microstentdevice

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

iStent Trabecular Micro Bypassdevice

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

Cataract removal and intraocular lens (IOL) implantationprocedure

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