PMCF Study on Monofocal Toric IOL (PODEYE TORIC)

Inclusion Criteria:

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

• Calculated IOL power (sphere and cylinder) is within the range of theinvestigational IOLs;

• Regular corneal astigmatism (measured by a topographer);

• Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) inone or both eyes;

• Capability to understand and sign an IRB approved informed consent form and privacyauthorization;

• Clear intraocular media other than cataract;

• Dilated pupil size large enough to visualize IOL axis markings postoperatively;

• Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOLimplantation;

• Willing and able to conform to the study requirements.

Exclusion Criteria:

• Age of patient <50 years at the day of screening;

• Regular corneal astigmatism <0.75 D or >4.25 D (measured by an automatickeratometer) in both eyes

• Irregular astigmatism (measured by a topographer);

• 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;

• History or presence of macular edema;

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

• Clinically significant, uncontrolled glaucoma with expected negative impact onContrast Sensitivity and/or visual acuity outcomes;

• Pregnant, lactating or, if able to bear children, unwilling to use medicallyacceptable birth control over the course of the study;

• Concurrent or previous (within 30 days) participation in another drug or deviceinvestigation;

• Clinically significant dry eye as determined by the investigator' s judgement;

• Ocular surface disease (clinical symptoms or keratitis);

• Patients showing contraindications as listed in the current Instructions for use (IFU);

• Unsuitable for study participation for any other reason, as determined byInvestigator's clinical judgment (reason to be documented on eCRF).

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.