Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens

Inclusion Criteria:

• Clinically documented age-related cataract in both eyes with no comorbidity;

• Calculated IOL power is within the range of the investigational IOLs;

• Male or female adults ages 50 years or older on the day of screening who havecataracts in both eyes;

• Regular corneal astigmatism (measured by topographer)

• Astigmatism ≤1.0 D (measured by an automatic keratometer)

• Clear intraocular media other than cataract;

• Availability, willingness and sufficient cognitive awareness to comply withexamination procedures;

• Patient is willing to receive bilateral implantation of a trifocal IOL (thisinclusion criteria applies only to the study group, not the control group);

• Signed informed consent.

Exclusion Criteria:

• Age of patient < 50 years;

• Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)

• Irregular astigmatism (measured by topographer);

• 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 with AMD suspicious eyes as determined by OCT examination;

• Previous intraocular or corneal surgery;

• Traumatic cataract;

• Instability of keratometry or biometry measurements; Acceptable maximum standarddeviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;

• Ocular hypertension, suspicious glaucoma or glaucoma;

• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupilsthat do not dilate under mesopic / scotopic conditions);

• Expected complicated surgery;

• Ocular surface disease (clinical symptoms or keratitis);

• Pregnancy or lactation;

• Second eye treatment will only be performed when Best Corrected Distance VisualAcuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);

• Concurrent 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;

• need for iris manipulation;

• 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.