Comparison of ISOPURE and EYHANCE (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 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 isallowed;

• 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 bilateralcataract surgery;

• Concurrent or previous (within 60 days) participation in another drug or deviceinvestigation.

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 befollowed until the condition has stabilized.