Safety & Effectiveness Study of the Hydrus Device for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ivantis, Inc.
Sponsor:
Information provided by (Responsible Party):
Ivantis, Inc.
ClinicalTrials.gov Identifier:
NCT01539239
First received: February 21, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.


Condition Intervention Phase
Primary Open Angle Glaucoma
Device: Hydrus Aqueous Implant
Procedure: Cataract surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Ivantis, Inc.:

Primary Outcome Measures:
  • Reduction in mean diurnal IOP from baseline at 24 months following medication washout. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean diurnal washed out IOP change from baseline at 24 months compared between treatment and control groups. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: January 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrus Aqueous Implant (Treatment)
Cataract surgery plus Hydrus Aqueous Implant
Device: Hydrus Aqueous Implant
The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
Active Comparator: Cataract Surgery (Control)
Cataract surgery only
Procedure: Cataract surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An operable age-related cataract
  • A diagnosis of POAG treated with 1 to 4 hypotensive medications
  • Medicated IOP ≤ 31 mmHg
  • Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg

Exclusion Criteria:

  • Congenital or developmental glaucoma
  • Previous argon laser trabeculoplasty
  • Ab-interno or ab-externo device implanted in or through Schlemm's Canal
  • Use of oral hypotensive medication for glaucoma for treatment of fellow 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: NCT01539239

Contacts
Contact: Brett Trauthen +1 949-600-9650 btrauthen@ivantisinc.com
Contact: Kerry Stephens, OD +1 949-600-9650 kstephens@ivantisinc.com

  Show 37 Study Locations
Sponsors and Collaborators
Ivantis, Inc.
Investigators
Principal Investigator: Alan Crandall, MD The Eye Institute of Utah
  More Information

No publications provided

Responsible Party: Ivantis, Inc.
ClinicalTrials.gov Identifier: NCT01539239     History of Changes
Other Study ID Numbers: CP-11-001
Study First Received: February 21, 2012
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ivantis, Inc.:
Glaucoma
POAG
Cataract

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

ClinicalTrials.gov processed this record on September 11, 2014