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NCT02024464 Clinical Trial

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

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02024464
Other study ID # CP-10-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date August 2018

Study information
Verified date May 2024
Source Ivantis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 306
Est. completion date August 2018
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Hydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
• iStent Trabecular Micro Bypass
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Procedure:
• Cataract removal and intraocular lens (IOL) implantation
Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ivantis, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12 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. Month 12: 8 am, 12 pm, 4 pm
Secondary Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12 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. Month 12: 8 am, 12 pm, and 4 pm
Secondary Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12 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. Month 12: 8 am, 12 pm, 4 pm
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