A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

Study Overview
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Brief Summary
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The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.

Official Title
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A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

Conditions
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Cataract

Intervention / Treatment
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* Device: Toric T3 - T9
* Device: IQ SN60WF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to understand and sign an informed consent; Willing and able to attend post-operative examinations per protocol schedule; In good ocular health, with the exception of cataracts; Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens; Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry; In good ocular health, with the exception of cataracts; Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Previous corneal surgery; Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures; Planned multiple procedures during cataract/IOL implantation surgery; Ocular disease and/or condition that may compromise study results; Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment; Pregnant or planning pregnancy during course of study; Participation in any other investigational study within 30 days prior to enrolment; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toric T3 - T9<br>AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye. | Device: Toric T3 - T9<br>* Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient<br>* Other names: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9;|
| Active Comparator: IQ SN60WF<br>AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye. | Device: IQ SN60WF<br>* Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient<br>* Other names: AcrySof® IQ IOL Model SN60WF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 | Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity. | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens, Toric