Single-center, Double-arm, Prospective Clinical Trial to Compare Visual Performance of Non-diffractive Extended Vision and Neutral Aspheric Monofocal Intraocular Lenses

Inclusion Criteria

• Male or female, age 18 or older at the time of study enrollment.
• Visually significant cataract in the study eyes for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated.
• Anticipated to undergo bilateral sequential cataract surgery
• Projected postoperative CDVA 0.20 logMAR (Snellen 20/32) or better in the study eyes, as determined by an Investigator's medical judgement.
• Calculated spherical power targeted at emmetropia at distance in the study eyes.
• Calculated IOL power between +15.0 - +25.0 D, inclusive, in both eyes.
• Measured against-the-rule astigmatism less than 0.6 D or with-the-rule/oblique astigmatism less than 1.25 D.
• If wearing rigid gas permeable (RGP) contact lens in the study eye, willingness to discontinue lens wear for ≥ 21 days prior to preoperative biometry.
• Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
• Willingness to sign the IRB-approved informed consent form (ICF) for study participation.

Exclusion Criteria

• Mature cataract in the study eye that is likely to prolong surgical procedure and/or lead to intraoperative complications prior to attempted IOL implantation.
• Any visually significant intraocular media opacity other than cataract in the study eye (as determined by the investigator). Such opacities might include corneal scar or vitreous hemorrhage.
• Abnormal corneal findings in the study eye (e.g. keratoconus, pellucid marginal degeneration, irregular astigmatism).
• Any anterior segment pathology in the study eye that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, clinically significant corneal dystrophies, poor pupil dilation, etc.)
• Any condition in the study eye that could affect IOL stability (e.g. pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.).
• History of severe dry eye in the study eye that, in the judgement of the investigator, would impair the ability to obtain reliable study measurements.
• History of serious corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.) in the study eye.
• History of any clinically significant retinal pathology or ocular diagnosis in the study eye that could, in the investigator's best judgement, alter or limit final post-operative visual prognosis (e.g. diabetic retinopathy, ischemic disease, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, aniridia, epiretinal membrane, etc.).
• History of cystoid macular edema in either eye.
• History of uveitis in either eye.
• History of intraocular or corneal surgery in the study eye besides laser peripheral iridotomy (LPI), selective laser trabeculoplasty (SLT), or argon laser trabeculoplasty (ALT).
• Uncontrolled glaucoma in the study eye (per Investigator judgement).
• Current ocular infection in the study eye.
• Presence of uncontrolled systemic disease that could increase operative risk (e.g. diabetes mellitus, mental illness, dementia, clinically significant atopic disease, etc.).
• Planned concomitant ocular procedure during cataract surgery inclusive of glaucoma surgery e.g. MIGS or limbal relaxing incisions.
• Symptoms that might be consistent with active COVID-19 including fever, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches.
• If COVID-19 positive, at least two weeks since last symptoms.
• Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement.