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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.

Conditions

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Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Pigmentary Dispersion Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hydrus Microstent

Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)

Group Type EXPERIMENTAL

Hydrus Microstent

Intervention Type DEVICE

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

Cataract removal and intraocular lens (IOL) implantation

Intervention Type PROCEDURE

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

iStent

Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)

Group Type ACTIVE_COMPARATOR

iStent Trabecular Micro Bypass

Intervention Type DEVICE

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

Cataract removal and intraocular lens (IOL) implantation

Intervention Type PROCEDURE

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

Interventions

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Hydrus Microstent

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

Intervention Type DEVICE

iStent Trabecular Micro Bypass

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

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
* An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.