Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

Study Overview
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Brief Summary
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The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

Detailed Description
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This study will be conducted in regions where the test article is approved at the time of study start.

Official Title
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Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision; Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures; Clear intraocular media other than cataract in both eyes; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema; Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies; Glaucoma (uncontrolled or controlled with medication) or ocular hypertension; Pregnant or lactating; Expected to require ocular surgical or retinal laser treatment; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 22 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: TFNT00<br>AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation | Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL<br>* Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient<br>* Other names: Model TFNT00;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Binocular Defocus Visual Acuity (VA) | Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned. | Day 20-40 and Day 120-180 from second eye implantation |