Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539239
• Other study ID #: CP-11-001
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: June 2020

Study information

• Verified date: February 2021
• Source: Ivantis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1143
• Est. completion date: June 2020
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

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.

Procedure:
• Cataract surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ivantis, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Mexico,  Philippines,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.	Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.	Baseline and 24 months
Secondary	Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.	Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.	Baseline and 24 months