Trial record 4 of 952 for:    "Glaucoma"

Compare the Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Having Cataract Surgery (Hydrus III)

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:
NCT02024464
First received: December 20, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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
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 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: Twelve months ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint for this study is IOP at 12 months following surgery.


Secondary Outcome Measures:
  • Proportion of patients requiring supplemental medication. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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: Month 12 ] [ Designated as safety issue: No ]
    The proportion of eyes with IOP greater than 5 and less than or equal to 19 mmHg at 12 months after surgery.

  • Loss of best-corrected visual acuity (BCVA) [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    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: January 2017
Estimated Primary Completion Date: December 2015 (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.

  Eligibility

Ages Eligible for Study:   21 Years and older
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 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 ClinicalTrials.gov identifier: NCT02024464

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: Iqbal K. Ahmed, MD Mississauga, ON, Canada
  More Information

No publications provided

Responsible Party: Ivantis, Inc.
ClinicalTrials.gov Identifier: NCT02024464     History of Changes
Other Study ID Numbers: CP-10-002
Study First Received: December 20, 2013
Last Updated: December 27, 2013
Health Authority: Canada: Health Canada
Austria: Austrian Medicines and Medical Devices Agency
Italy: Ministry of Health
Spain: Spanish Agency of Medicines
Poland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014