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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

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

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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

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