Safety & Effectiveness Study of the Hydrus Device for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery
This study is currently recruiting participants.
Verified October 2012 by Ivantis, Inc.
Sponsor:
Ivantis, Inc.
Information provided by (Responsible Party):
Ivantis, Inc.
ClinicalTrials.gov Identifier:
NCT01539239
First received: February 21, 2012
Last updated: October 19, 2012
Last verified: October 2012
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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 to 80 Years |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539239
Contacts
| Contact: Kerry Stephens, OD | KStephens@ivantisinc.com |
Locations
| United States, Arkansas | |
| Recruiting | |
| Springdale, Arkansas, United States | |
| United States, California | |
| Recruiting | |
| Sacramento, California, United States | |
| United States, Colorado | |
| Recruiting | |
| Fort Collins, Colorado, United States | |
| Recruiting | |
| Parker, Colorado, United States | |
| United States, Iowa | |
| Recruiting | |
| Sioux City, Iowa, United States | |
| United States, Texas | |
| Recruiting | |
| Austin, Texas, United States | |
| Recruiting | |
| Dallas, Texas, United States | |
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: | October 19, 2012 |
| 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 June 18, 2013