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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ivantis, Inc. Identifier:
First received: December 20, 2013
Last updated: May 9, 2017
Last verified: May 2017
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.

Condition Intervention
Primary Open Angle Glaucoma
Pseudoexfoliative Glaucoma
Pigmentary Dispersion Glaucoma
Device: Hydrus Microstent
Device: iStent Trabecular Micro Bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

Resource links provided by NLM:

Further study details as provided by Ivantis, Inc.:

Primary Outcome Measures:
  • Intraocular pressure at Month 12 [ Time Frame: 24 months ]
    The primary effectiveness endpoint for this study is IOP at 24 months following surgery.

Secondary Outcome Measures:
  • Proportion of patients requiring supplemental medication. [ Time Frame: 24 months ]
    The proportion of patients requiring supplemental medication for pressure control.

Other Outcome Measures:
  • Proportion of eyes with IOP greater than 5 and less than or equal to 19 mmHg. [ Time Frame: 24 months ]
    The proportion of eyes with IOP greater than 5 and less than or equal to 19 mmHg at 24 months after surgery.

  • Loss of best-corrected visual acuity (BCVA) [ Time Frame: 24 months ]
    Safety outcomes include loss of lines of BCVA, results of slit lamp and fundus examination, and the incidence of complications and adverse events.

Estimated Enrollment: 300
Study Start Date: August 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
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.

Ages Eligible for Study:   21 Years and older   (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 dispersion glaucoma (PDG)
  • An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.

Exclusion Criteria:

  • Forms of primary or secondary glaucoma not listed above
  • Prior glaucoma surgery in the study eye
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02024464

United States, California
Contact Paul Rhee at Ivantis
Irvine, California, United States, 92618
Sponsors and Collaborators
Ivantis, Inc.
Principal Investigator: Iqbal K. Ahmed, MD Mississauga, ON, Canada
  More Information

Responsible Party: Ivantis, Inc. Identifier: NCT02024464     History of Changes
Other Study ID Numbers: CP-10-002
Study First Received: December 20, 2013
Last Updated: May 9, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases processed this record on May 22, 2017