Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL

Exclusion Criteria

• •1. Regular corneal astigmatism \>1.0 D (measured by IOL Master) in one or both eyes;
• •2. Irregular astigmatism (measured by a topographer) in both eyes;
• •3. Difficulties for cooperation;
• •4. Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity loss to 20/30 or worse in one or both eyes;
• •5. Subjects with AMD suspicious eyes as determined by OCT examination;
• •6. Previous intraocular or corneal surgery in one or both eyes;
• •7. Traumatic cataract in one or both eyes as judged by investigator;
• •8. History or presence of macular edema in one or both eyes;
• •9. Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D in both eyes;
• •10. Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and / or visual acuity outcomes in one or both eyes;
• •11. Pupil abnormalities (non-reactive, tonic, abnormally shaped) in one or both eyes;
• •12. Subjects that cannot achieve a minimum pharmacologic pupilar dilatation of 5 mm in one or both eyes;
• •13. Complicated surgery expected;
• •14. Ocular surface disease (clinical symptoms) in one or both eyes;
• •15. Clinically significant dry eye as determined by the investigator's judgement in one or both eyes;
• •16. Anterior segment pathology that might increase intraoperative risk or compromise IOL stability;
• •17. Diabetic retinopathy;
• •18. Congenital ocular anomalies;
• •19. Chronic or recurrent inflammatory eye diseases;
• •20. Active infectious conjunctivitis, keratitis or uveitis in either eye within 30 days prior to surgery;
• •21. Subjects who may be expected to require a combined or other surgical procedure in either eye;
• •22. Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
• •23. Concurrent or previous (within 30 days) participation in another drug or device investigation;
• •24. Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome);
• •25. Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens;
• •26. Subjects who are expected to require retinal laser treatment;
• •27. Patients showing contraindications as listed in the current Instructions for use (IFU);
• •28. Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
• •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.