Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients
Cataract surgery presents an extremely high success rate in improving vision and quality of life and it is currently the most commonly performed ophthalmic surgery, especially considering its growing utility in the aging population (e.g., more than 20 million worldwide underwent the procedure in 2015); it is possible to affirm that benefits clearly outweigh risks. However, although cataract surgery is highly effective and relatively safe, owing to the enormous numbers, even uncommon surgical complications could potentially harm the patients. For this reason, it is essential to continue to consider the possible risks and undesirable side-effects associated to cataract surgery, such as post-cataract endophthalmitis (POE), postcataract opacification (PCO), PCME, dysphotopsias, retinal detachment, and IOL dislocation.
⁃ Subjects will be deemed eligible for the study if all of the following inclusion criteria are met:
• Older than eighteen years of age at the time of surgery and diagnosed with cataract;
• Unilateral or bilateral cataract removal by phacoemulsification;
• Correction of resulting aphakia with the Mini 4 Ready IOL. Indication for use of the Mini 4 Ready should be previous to and not conditioned by study participation.
• In case of bilateral cataract, subject able to underwent second cataract surgery within 1 months from first implant and not before 7 days;
• Willing and able to complete all required postoperative visits;
• Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.