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

Primary Purpose

Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Dispersion Glaucoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hydrus Microstent

iStent Trabecular Micro Bypass

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary dispersion glaucoma, PDG, Hydrus

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

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

Sites / Locations

Contact Richard Hope at Ivantis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrus Microstent

iStent Trabecular Micro Bypass

Arm Description

Patients randomized to the Hydrus Microstent

Patients randomized to the iStent Trabecular Micro Bypass

Outcomes

Primary Outcome Measures

Intraocular pressure at Month 12

The primary effectiveness endpoint for this study is IOP at 12 months following surgery.

Secondary Outcome Measures

Proportion of patients requiring supplemental medication.

The proportion of patients requiring supplemental medication for pressure control.

Full Information

NCT ID

NCT02024464

First Posted

December 20, 2013

Last Updated

August 22, 2019

Sponsor

Ivantis, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02024464

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ivantis, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Dispersion Glaucoma

Keywords

Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary dispersion glaucoma, PDG, Hydrus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrus Microstent

Arm Type

Experimental

Arm Description

Patients randomized to the Hydrus Microstent

Arm Title

iStent Trabecular Micro Bypass

Arm Type

Active Comparator

Arm Description

Patients randomized to the iStent Trabecular Micro Bypass

Intervention Type

Device

Intervention Name(s)

Hydrus Microstent

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

iStent Trabecular Micro Bypass

Intervention Description

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

Primary Outcome Measure Information:

Title

Intraocular pressure at Month 12

Description

The primary effectiveness endpoint for this study is IOP at 12 months following surgery.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Proportion of patients requiring supplemental medication.

Description

The proportion of patients requiring supplemental medication for pressure control.

Time Frame

24 months

Other Pre-specified Outcome Measures:

Title

Proportion of eyes with IOP greater than 5 and less than or equal to 19 mmHg.

Description

The proportion of eyes with IOP greater than 5 and less than or equal to 19 mmHg at 24 months after surgery.

Time Frame

24 months

Title

Loss of best-corrected visual acuity (BCVA)

Description

Safety outcomes include loss of lines of BCVA, results of slit lamp and fundus examination, and the incidence of complications and adverse events.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iqbal K. Ahmed, MD

Organizational Affiliation

Mississauga, ON, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Contact Richard Hope at Ivantis

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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