Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma; Pseudoexfoliative Glaucoma; Pigmentary Dispersion Glaucoma
• Interventions: Device: iStent Trabecular Micro Bypass; Device: Hydrus Microstent; Procedure: Cataract removal and intraocular lens (IOL) implantation

• Registration Number: NCT02024464
• Lead Sponsor: Ivantis, Inc.

Brief Summary

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.

Detailed Description

This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Primary Completion: 2017-03
• Study Completion: 2018-08
• Results First Submitted: 2024-02-19
• Results First Submitted QC: 2024-05-28
• Status Verified: 2024-06
• Results First Posted: 2024-06-21
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
• An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.

Exclusion Criteria

• Forms of primary or secondary glaucoma not listed above
• Prior glaucoma surgery in the study eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iStent	iStent Trabecular Micro Bypass	Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Hydrus Microstent	Hydrus Microstent	Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)
iStent	Cataract removal and intraocular lens (IOL) implantation	Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Hydrus Microstent	Cataract removal and intraocular lens (IOL) implantation	Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)

Primary Outcome Measures

Name	Time	Method
Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12	Month 12: 8 am, 12 pm, 4 pm	Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12	Month 12: 8 am, 12 pm, and 4 pm	Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.
Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12	Month 12: 8 am, 12 pm, 4 pm	Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.