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.
• Adults (22 years of age or older at the time of surgery) of any gender and race, diagnosed with age related cataracts in one eye.
• Preoperative best corrected distance visual acuity (BCDVA) of 20/32 or worse.
• Projected postoperative BCDVA 0.20 logMAR or better in the study eye, as determined by Investigator's medical judgment.
• Calculated spherical power targeted at emmetropia at distance in the study eye.
• Calculated lens power within the available range for the Eyedeal® Model PX65AS1 IOL (+0.50D - +34.00D).
• Planned cataract removal by phacoemulsification procedure.
• Clear intraocular media other than cataract, in the study eye.
• Pharmacologically dilated pupil size of at least 6.0mm.
• 2.0 D or less of preoperative astigmatism in the study eye.
⁃ Willing and able to complete all required postoperative visits.
⁃ Able to comprehend and sign or through a representative, with a witness present, a statement of IRB or EC approved Informed Consent Form (ICF).