Comparison of ISOPURE and EYHANCE (Switzerland)

- 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 have cataract(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 with examination procedures;

- Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;

- Signed informed consent.

- 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 or other retinal or optic disorders);

- Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema or macula pucker; previous laser treatment for peripheral retinal tears is allowed;

- Previous intraocular or corneal surgery or intravitreal injection;

- Traumatic cataract;

- History or presence of macular edema;

- Glaucoma with visual field defects; or RNFL defects on OCT; ocular hypertension is allowed;

- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that 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 cataract surgery;

- Concurrent or previous (within 60 days) participation in another drug or device investigation. In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when 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 be followed until the condition has stabilized.