Clinical Trial

Hydrus® Microstent New Enrollment Post-Approval Study

Study acronym: CONFIRM
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2028-06 -> 2028-08 2026-07-15
minor Completion pushed: 2028-06 -> 2028-08 2026-07-15
Trial Details
NCT Number NCT04553523
Lead Sponsor Alcon Research
Conditions Primary Open Angle Glaucoma
Enrollment 545 participants
Start Date 2020-08-25
Primary Completion 2028-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-14