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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Toric T3 - T9; Device: IQ SN60WF

• Registration Number: NCT01225926
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Study Start: 2011-03
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-07-22
• Results First Submitted QC: 2013-07-22
• Status Verified: 2013-09
• Results First Posted: 2013-09-24
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toric T3 - T9	Toric T3 - T9	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.
IQ SN60WF	IQ SN60WF	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.

Primary Outcome Measures

Name	Time	Method
Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3	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.