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

Ivantis

Status: Completed

Conditions: Primary Open Angle Glaucoma; Pseudoexfoliative Glaucoma; Pigmentary Dispersion Glaucoma

Treatments: Device: iStent Trabecular Micro Bypass; Device: Hydrus Microstent; Procedure: Cataract removal and intraocular lens (IOL) implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02024464

CP-10-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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306 participants in 2 patient groups

Hydrus Microstent

Experimental group

Description:

Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)

Treatment:

Procedure: Cataract removal and intraocular lens (IOL) implantation

Device: Hydrus Microstent

iStent

Active Comparator group

Description:

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

Treatment:

Procedure: Cataract removal and intraocular lens (IOL) implantation

Device: iStent Trabecular Micro Bypass