Hydrus® Microstent New Enrollment Post-Approval Study (CONFIRM) 

STUDY OVERVIEW

The purpose of this post-approval study by Alcon Research is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae within 24 months post-operation. Subjects will undergo cataract surgery with monofocal intraocular lens placement, followed by Hydrus Microstent implantation. Participants will attend a screening visit, a surgical visit (Day 0), and 8 postoperative visits at Day 1, Day 7, and Months 1, 3, 6, 12, 18, and 24. The study was initiated by Ivantis, Inc. and is now sponsored by Alcon Research following their acquisition of Ivantis in November 2022.

STUDY GOALS

The goal of this study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae within 24 months post-operation in patients undergoing cataract surgery with monofocal intraocular lens placement and Hydrus Microstent implantation. Participants will be monitored through a series of scheduled visits over the 24-month period.

LOCATION

El Paso, Texas: El Paso Eye Surgeons, P.A.

INCLUSION CRITERIA

  • Operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse

  • Diagnosis of primary open-angle glaucoma treated with no more than 4 topical hypotensive medications

  • Optic nerve appearance characteristic of glaucoma

  • Medicated intraocular pressure (IOP) ≤ 31 mmHg

  • Other protocol-defined inclusion criteria may apply

EXCLUSION CRITERIA

  • Closed angle forms of glaucoma

  • Congenital or developmental glaucoma

  • Secondary glaucoma

  • Use of more than 4 ocular hypotensive medications

  • Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or other prior filtration or cilioablative surgery

  • Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal

  • Other protocol-defined exclusion criteria may apply

For more information, visit ClinicalTrials.gov.