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NCT Number: NCT02024464

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

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Pigmentary Dispersion Glaucoma Pseudoexfoliative Glaucoma

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrus Microstent

Device

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

iStent Trabecular Micro Bypass

Device

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

Cataract removal and intraocular lens (IOL) implantation

Procedure

Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects

Primary outcomes

  1. Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12

    Time frame: 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 outcomes

  1. Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12

    Time frame: 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.

  2. Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ivantis, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Dec 31, 2013
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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