A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
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|ClinicalTrials.gov Identifier: NCT01225926|
Recruitment Status : Completed
First Posted : October 21, 2010
Results First Posted : September 24, 2013
Last Update Posted : October 29, 2013
Information provided by (Responsible Party):
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.
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: Toric T3 - T9 Device: IQ SN60WF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: 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.
Device: Toric T3 - T9
Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient
Other Name: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9
Active Comparator: 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.
Device: IQ SN60WF
Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient
Other Name: AcrySof® IQ IOL Model SN60WF
Primary Outcome Measures :
- Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 [ Time Frame: 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.
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