The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
Alcon Research
Summary
The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.
Description
Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * An 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 IOP less than or equal to 31 millimeters mercury (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 trabeculop…
Interventions
- DeviceHydrus Microstent
Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL.
- ProcedureCataract surgery
Cataract surgery performed using standard anesthesia and phacoemulsification techniques
- DeviceMonofocal IOL
Commercially available monofocal intraocular lens as determined by the investigator
Locations (22)
- Coastal VisionIrvine, California
- Sacramento Eye ConsultantsSacramento, California
- Eye Center of Northern ColoradoLoveland, Colorado
- Jones Eye Center PCSioux City, Iowa
- Stiles Eyecare Excellence Cataracts and GlaucomaOverland Park, Kansas
- Visionary Eye DoctorsRockville, Maryland