PMCF Study of Preloaded Trifocal IOL

Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System

This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.

This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.

Inclusion Criteria:

• Bilateral cataracts: Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts
• Desire for high post-operative spectacle independence
• Willingness to cooperate with and complete all post-operative visits
• Calculated lens power within +5.0 D and +34.0 D
• Planned cataract removal by phacoemulsification
• Clear intraocular media other that cataracts in both eyes
• Potential post-operative visual acuity of 20/25 or better
• Ability to comprehend and sign an informed consent
• Signed informed consent

Exclusion Criteria:

• More than 1.0 D of pre-operative corneal astigmatism
• Expected post-operative astigmatism of more than 0.75 D
• Mature/dense cataract which makes the pre-operative fundus examination difficult
• Previous ocular surgery or trauma
• Clinically significant irregular astigmatism
• Choroidal hemorrhage
• Microphthalmos
• Severe corneal dystrophy
• Medically controlled or uncontrolled glaucoma
• Clinically significant macular/RPE changes
• Concomitant severe eye disease
• Severe optic nerve atrophy
• Diabetic retinopathy, proliferative or macular edema
• Amblyopia
• Extremely shallow anterior chamber
• Chronic sever uveitis
• Pregnant or lactating
• Previous retinal detachment
• Previous corneal transplant
• Concurrent participation in another drug or device investigation
• May be expected to require other ocular surgery during the study