PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Europe (PHY2104) (PHY2104)

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, Monofocal, Toric Lens Read More

Inclusion Criteria:

• Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes;
• Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;
• Regular corneal astigmatism (measured by a topographer);
• Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes;
• Capability to understand and sign an IRB approved informed consent form and privacy authorization;
• 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 IOL implantation;
• 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 automatic keratometer) in both eyes
• Irregular astigmatism (measured by a topographer);
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other 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 standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
• Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes;
• Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
• Concurrent or previous (within 30 days) participation in another drug or device investigation;
• 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 by Investigator'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 be followed until the condition has stabilized.