Evaluation of Safety and Effectiveness of an IOL With a Virtual Aperture Optic

Exclusion Criteria

• •1. Desire for monovision correction
• •2. History of Dry Eye treatments/devices (example IPL, Lipiflow, iLux, Tear Care, Bruder Mask, True Tear) or any dry eye medications other than artificial tears (example, Restasis, Xiidra, Cequa, Klarity-C, generic cyclosporine/compounded cyclosporine)
• •3. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, Reiter's syndrome, etc.);
• •4. Clinically significant corneal abnormalities or defects including corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), irregularity (including irregularity due to dry eye syndrome), inflammation or edema per the Investigator's expert medical opinion. Note: conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded;
• •5. Previous corneal or intraocular surgery;
• •6. Irregular corneal astigmatism; or regular corneal astigmatism greater than or equal to +/-0.75D;
• •7. Inability to achieve stable keratometric readings for contact lens wearers;
• •\*The recommended time for discontinued wear of extended-wear or daily wear soft lenses is one week prior to surgery, one month for gas permeable and six months for PMMA lenses. No evidence of significant corneal warpage from contact lens use should be present on corneal topography and if the subject has been wearing a rigid gas permeable contact lens there should be two stable serial topographies at least 1 month following cessation of contact lens wear
• •8. Higher-order Zernike corneal aberrations (3rd -order and above) RMS value greater than 1.0 um for the central 6-mm diameter area;
• •9. Pupil dilation in scotopic conditions \>5mm
• •10. Use of systemic or ocular medications that may affect vision or likely to impact pupil dilation or iris structure;
• •11. Pharmacologically dilated pupil size less than 6 mm in either eye;
• •12. Pupil abnormalities;
• •13. History of ocular trauma, prior refractive or other ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention;
• •14. Any disease or pathology, other than cataract, that (in the expert opinion of the Investigator) is expected to reduce the potential postoperative BCDVA. Note: Conditions including, but not limited to the following: amblyopia, clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), diabetic retinopathy, extremely shallow anterior chamber, not due to swollen cataract, microphthalmos, previous retinal detachment, previous corneal transplant, recurrent severe anterior or posterior segment inflammation of unknown etiology, iris; neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy, or diagnosis of pseudoexfoliation;
• •15. Neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy;
• •16. Subjects who have profound sensitivity to glare at night with oncoming traffic headlights or subjects who are sensitive to fluorescent light flicker;
• •17. Subjects who may reasonably be expected to require a SSI at any time during the study (other than YAG capsulotomy);
• •18. Subject is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye. Females of childbearing age must have a negative pregnancy test at screening in order to be enrolled into the study.
• •19. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit;
• •20. Acute, chronic, or uncontrolled systemic or ocular disease or any illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., poorly-controlled diabetes);