CLINICAL OUTCOMES AFTER IMPLANTATION OF THE ACRYSOF® IQ RESTOR® +2.5 D MULTIFOCAL INTRAOCULAR LENS (MIOL) IN THE DOMINANT EYE AND RANDOMIZATION OF THE ACRYSOF® IQ RESTOR® +2.5 D OR +3.0 D MIOL IN THE FELLOW EYE - ACRYSOF® IQ RESTOR® +2.5 D MIOL versus ACRYSOF® IQ RESTOR® +3.0 D MIO

Alcon Laboratories0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•1.are adult patients 21 years of age or older at the time of surgery, of either gender or any race;
•2.are willing and able to understand and sign an informed consent;
•3.are willing and able to attend postoperative examinations per protocol schedule;
•4.require cataract extraction followed by posterior IOL implantation used as an on-label procedure in both eyes;
•5.be willing to have second eye surgery within 45 days of first eye surgery;
•6.are free of severe disease(s)/condition(s) listed in the *Warnings* and *Precautions* section of the AcrySof® IQ ReSTOR® +2.5 D and AcrySof® IQ ReSTOR® +3.0 D MIOL package inserts;
•7.are expected to have postoperative astigmatism < 1.0 D in both eyes, measured by keratometry.

•1.Refractive lens exchange (CDVA should be worse than 20/20);
•2.Significant irregular corneal astigmatism as demonstrated by corneal topography;
•3.Patients diagnosed with severe degenerative visual disorders (e.g. macular degeneration or other retinal disorders);
•4.Previous corneal surgery;
•5.Amblyopia;
•6.Planned multiple procedures, including LRI, LASIK, etc. during surgery or the course of this study;
•7.Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy);
•8.History of corneal disease (e.g., herpes simplex, herpes zoster, etc.);
•9.Severe diabetic retinopathy;
•10.History of retinal detachment;
•11.Patients who have severe conditions of acute or chronic diseases or illnesses that, per investigator*s clinical judgment, would increase the operative risk or confound the results of this investigation;
•12.Any patient currently participating in another drug or device study;
•13.Pregnant or planning pregnancy during course of study.

发起方

Alcon Laboratories