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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04553523
Study type Interventional
Source Alcon Research
Contact Alcon Call Center
Phone 1-888-451-3937
Status Recruiting
Phase N/A
Start date August 25, 2020
Completion date January 2027

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