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Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes

NCT ID: NCT02023242

Last Updated: 2019-12-10

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

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-01-31

Brief Summary

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This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.

Detailed Description

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This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.

Conditions

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Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Pigmentary Glaucoma

Keywords

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Primary open angle glaucoma POAG Pseudoexfoliative glaucoma PXG Pigmentary glaucoma PG Hydrus

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

Patients randomized to the Hydrus Microstent .

Group Type EXPERIMENTAL

Hydrus Microstent

Intervention Type DEVICE

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

iStent Trabecular Micro Bypass

Patients randomized to the iStent Trabecular Micro Bypass

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.

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

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
* A phakic lens with BCVA of 20/30 or better

Exclusion Criteria

* Forms of primary or secondary glaucoma not listed above
* Prior glaucoma surgery in the study eye
Minimum Eligible Age

45 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ivantis, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julian Garcia Feijoo, Prof. Med.

Role: PRINCIPAL_INVESTIGATOR

Madrid, Spain

Locations

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Contact Richard Hope at Ivantis

Irvine, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CP-12-001

Identifier Type: -

Identifier Source: org_study_id