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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Ivantis, Inc.
Sponsor:
Information provided by (Responsible Party):
Ivantis, Inc.
ClinicalTrials.gov Identifier:
NCT02023242
First received: December 23, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Ivantis, Inc.:

Primary Outcome Measures:
  • Intraocular pressure at Month 12 [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint for this study is IOP at 12 months following surgery.


Secondary Outcome Measures:
  • Medication use at 12 and 24 months [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    Mean medication use at 12 and 24 months post procedure


Other Outcome Measures:
  • Safety outcomes [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: Yes ]
    Safety outcomes include complications and adverse events.


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2016 (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 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.

  Eligibility

Ages Eligible for Study:   45 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT02023242

Contacts
Contact: Brett Trauthen 949/333-1315 btrauthen@ivantisinc.com
Contact: Paul Rhee, OD 949/333-1316 prhee@ivantisinc.com

Locations
United States, California
Contact Brett Trauthen at Ivantis Recruiting
Irvine, California, United States, 92618
Sponsors and Collaborators
Ivantis, Inc.
Investigators
Principal Investigator: Julian Garcia Feijoo, Prof. Med. Madrid, Spain
  More Information

No publications provided

Responsible Party: Ivantis, Inc.
ClinicalTrials.gov Identifier: NCT02023242     History of Changes
Other Study ID Numbers: CP-12-001
Study First Received: December 23, 2013
Last Updated: December 23, 2013
Health Authority: Spain: Spanish Agency of Medicines
Poland: Ethics Committee
Italy: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Mexico: Ministry of Health
Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by Ivantis, Inc.:
Primary open angle glaucoma
POAG
Pseudoexfoliative glaucoma
PXG
Pigmentary glaucoma
PG
Hydrus

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

ClinicalTrials.gov processed this record on August 20, 2014