NCT04553523

Hydrus® Microstent New Enrollment Post-Approval Study

The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 545 (estimated)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Hydrus 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.
PROCEDURE	Cataract surgery	Cataract surgery performed using standard anesthesia and phacoemulsification techniques
DEVICE	Monofocal IOL	Commercially available monofocal intraocular lens as determined by the investigator

Timeline

• Start date: 2020-08-25
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2020-09-17
• Last updated: 2025-06-03

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study