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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539239
First Posted: February 27, 2012
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ivantis, Inc.
  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
Primary Open Angle Glaucoma Device: Hydrus Aqueous Implant Procedure: Cataract surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Mean diurnal washed out IOP change from baseline at 24 months compared between treatment and control groups. [ Time Frame: 24 months ]

Enrollment: 1143
Study Start Date: January 2012
Estimated Study Completion Date: June 2020
Primary Completion Date: June 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01539239


  Show 38 Study Locations
Sponsors and Collaborators
Ivantis, Inc.
Investigators
Principal Investigator: Alan Crandall, MD The Eye Institute of Utah
  More Information

Responsible Party: Ivantis, Inc.
ClinicalTrials.gov Identifier: NCT01539239     History of Changes
Other Study ID Numbers: CP-11-001
First Submitted: February 21, 2012
First Posted: February 27, 2012
Last Update Posted: September 8, 2017
Last Verified: September 2017

Keywords provided by Ivantis, Inc.:
Glaucoma
POAG
Cataract

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