PMCF Study on Comparison of EDOF Lenses (Switzerland)

Inclusion Criteria:

• Cataractous eyes with no comorbidity;
• Calculated IOL power is within the range of the study IOLs;
• Male or female adults ages 50 years or older on the day of screening who havecataract(s) in one or both eyes;
• Regular total corneal astigmatism ≤1.0 D (measured by topography method)
• Clear intraocular media other than cataract;
• Availability, willingness and sufficient cognitive awareness to comply withexamination procedures;
• Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;
• Signed informed consent.

Exclusion Criteria:

• Age of patient < 50 years;
• Regular total corneal astigmatism >1.0 dioptres (measured by topography method)
• Irregular astigmatism;
• Difficulty for cooperation (distance from their home, general health conditions);
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration orother retinal or optic disorders);
• Subjects who may be expected to require retinal laser treatment during the course ofthe study or at a greater risk of developing cystoid macular edema or macula pucker;
• Previous intraocular or corneal surgery or intravitreal injection;
• Traumatic cataract;
• History or presence of macular edema;
• Glaucoma with visual field defects;
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupilsthat do not dilate under mesopic / scotopic conditions);
• Amblyopia with monocular preoperative CDVA of >0.1 logMAR;
• Cornea guttata;
• Keratoconus;
• Chronic uveitis;
• Expected complicated surgery;
• Significant dry eye;
• Contra-indications as listed in the current Instructions for use (IFU);
• Contra-indication or unwillingness to perform immediate sequential bilateral cataractsurgery;
• Concurrent or previous (within 60 days) participation in another drug or deviceinvestigation. In addition to above mentioned in- and exclusion criteria, subjects shall be discontinuedwhen certain conditions are present at the time of surgery, including:
• zonular instability or defect;
• capsular fibrosis or other opacity; and
• inability to fixate IOL in desired position. In such cases, the subject shall befollowed until the condition has stabilized.