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

A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure 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.

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.

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