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Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Sponsor: Kowa Research Institute, Inc.
Summary
A study to learn how well an artificial lens, called an intraocular lens (IOL), works in adults who have cataract surgery. During this type of surgery, the eye's natural lens is removed and replaced with an artificial lens to help restore vision. The main goal of the study is to evaluate vision after the lens is placed in the eye. About one year after surgery, participants' vision will be measured to understand how clearly they can see. The study will also look at how the lens performs over time, including how well it remains in place in the eye. The results of this study will help provide more information about how this lens performs in adults undergoing cataract surgery.
Official title: A Prospective, Multicenter, Open-label, Single-arm Clinical Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) IOL for Correction of Aphakia Following Cataract Extraction
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2026-08
Completion Date
2028-11
Last Updated
2026-06-16
Healthy Volunteers
No
Conditions
Interventions
KI-362-US1 (YP2.2VM)
Injector and one-piece (1P) monofocal IOL