PMCF Study of Preloaded Trifocal IOL

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Trifocal Preloaded IOL Delivery System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trifocal Preloaded IOL Delivery System<br>Bilateral trifocal IOLs implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery | Device: Trifocal Preloaded IOL Delivery System<br>* UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan.<br>* Other names: TF60;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photopic monocular CDVA, 400 cm |  | 6 Months post second eye implantation | 
| Photopic monocular CIVA, 60 cm |  | 6 Months post second eye implantation | 
| Photopic monocular CNVA, 40 cm |  | 6 Months post second eye implantation | 
| Rates of adverse events vs. ISO 11979-7:2018 SPE rate |  | 6 Months post second eye implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Trifocal, IOL, Intraocular lens, Preloaded, Aphakic, Spectacle independence, Asqelio, aspicio, AST Products, ICARES