Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
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|ClinicalTrials.gov Identifier: NCT01539239|
Recruitment Status : Active, not recruiting
First Posted : February 27, 2012
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Open Angle Glaucoma||Device: Hydrus Aqueous Implant Procedure: Cataract surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2020|
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.
- Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. [ Time Frame: Baseline and 24 months ]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.
- Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. [ Time Frame: Baseline and 24 months ]Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.
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
|Principal Investigator:||Alan Crandall, MD||The Eye Institute of Utah|