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

Sponsor

Ivantis, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02024464

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Pigmentary Dispersion Glaucoma	Device: Hydrus Microstent Device: iStent Trabecular Micro Bypass	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hydrus Microstent Patients randomized to the Hydrus Microstent	Device: Hydrus Microstent Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Active Comparator: iStent Trabecular Micro Bypass Patients randomized to the iStent Trabecular Micro Bypass	Device: iStent Trabecular Micro Bypass Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

Arm

Intervention/Treatment

Experimental: Hydrus Microstent

Patients randomized to the Hydrus Microstent

Device: Hydrus Microstent

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

Active Comparator: iStent Trabecular Micro Bypass

Patients randomized to the iStent Trabecular Micro Bypass

Device: iStent Trabecular Micro Bypass

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

Outcome Measures

Primary Outcome Measures

Intraocular pressure at Month 12 [24 months]
The primary effectiveness endpoint for this study is IOP at 12 months following surgery.

Secondary Outcome Measures

Proportion of patients requiring supplemental medication. [24 months]
The proportion of patients requiring supplemental medication for pressure control.

Other Outcome Measures

Proportion of eyes with IOP greater than 5 and less than or equal to 19 mmHg. [24 months]
The proportion of eyes with IOP greater than 5 and less than or equal to 19 mmHg at 24 months after surgery.
Loss of best-corrected visual acuity (BCVA) [24 months]
Safety outcomes include loss of lines of BCVA, results of slit lamp and fundus examination, and the incidence of complications and adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.