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

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ClinicalTrials.gov Identifier: NCT02023242
Recruitment Status : Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):
Ivantis, Inc.

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

Condition or disease Intervention/treatment
Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Pigmentary Glaucoma Device: Hydrus Microstent Device: iStent Trabecular Micro Bypass

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
Study Start Date : October 2012
Primary Completion Date : May 2015
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hydrus Microstent
Patients randomized to the Hydrus Microstent .
Device: Hydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Active Comparator: iStent Trabecular Micro Bypass
Patients randomized to the iStent Trabecular Micro Bypass
Device: iStent Trabecular Micro Bypass
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

Primary Outcome Measures :
  1. Response rate at Month 12 [ Time Frame: Twelve months ]
    The primary effectiveness endpoint for this study is difference in proportion of subjects unmedicated at 12 months following surgery.

Secondary Outcome Measures :
  1. Medication use at 12 and 24 months [ Time Frame: Months 12 and 24 ]
    Mean medication use at 12 and 24 months post procedure

Other Outcome Measures:
  1. Safety outcomes [ Time Frame: Months 12 and 24 ]
    Safety outcomes include complications and adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023242

United States, California
Contact Paul Rhee at Ivantis
Irvine, California, United States, 92618
Sponsors and Collaborators
Ivantis, Inc.
Principal Investigator: Julian Garcia Feijoo, Prof. Med. Madrid, Spain

Responsible Party: Ivantis, Inc.
ClinicalTrials.gov Identifier: NCT02023242     History of Changes
Other Study ID Numbers: CP-12-001
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Ivantis, Inc.:
Primary open angle glaucoma
Pseudoexfoliative glaucoma
Pigmentary glaucoma

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases