PMCF Study on Monofocal Toric IOL (PODEYE TORIC) (PHY2101)

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.