Lens Implantation, Intraocular Clinical Trial
Official title:
A Prospective, Multicenter Study to Evaluate Safety and Performance Outcomes of Eyedeal Intraocular Lens Implantation After Cataract Removal
A cataract is the clouding of the natural lens in the eye and is very common as when getting older. A cloudy lens makes it difficult to see. A cataract is treated by removing the cloudy lens and replacing it with an intraocular lens (known as an IOL). The goal of this clinical trial is to determine if the Eyedeal® IOL can be safely implanted in a subject's eye and if it can replace efficiently the natural lens. Subjects will be asked to attend a total of seven visits for this study for a period of 12 months after surgery.
To investigate the safety and performance of the Eyedeal® PX65AS1 intraocular lens (IOL) - To evaluate the safety profile with regards to best-corrected visual acuity, and adverse events - To evaluate the performance with regards of best corrected distance VA after the device implantation The Eyedeal® IOL (PX65AS1) is a foldable single-piece ultra-violet absorbing posterior chamber intraocular lens (IOL). It is an optical implant to replace the human crystalline lens in the visual correction of aphakia in adult patients after cataract removal. The Eyedeal® PX65AS1 IOL lens is made of a high refractive index soft cross-linked polyolefin. The Eyedeal® PX65AS1 IOL lens has an aspheric optic with symmetric optic design and spherical neutral and correct lens's own spherical aberration supporting haptics to provide proper position of the IOL optic within the capsule. ;
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