A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01045733

First received: January 8, 2010

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 8, 2010
Last Updated Date	November 27, 2012
Start Date ^ICMJE	December 2009
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 27, 2012)	Corneal Aberration [ Time Frame: Month 6 postoperative ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: January 8, 2010)	Corneal Aberration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01045733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 27, 2012)	Visual Acuity [ Time Frame: Month 6 postoperative ] [ Designated as safety issue: No ] Corneal Cylinder [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 8, 2010)	Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ] Corneal Cylinder [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
Official Title ^ICMJE	A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation
Brief Summary	The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Cataract Astigmatism
Intervention ^ICMJE	Device: AcrySof IQ Toric IOL AcrySof IQ Toric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Other Names: AcrySof IQ Toric IOL Model SN6AT3 AcrySof IQ Toric IOL Model SN6AT4 AcrySof IQ Toric IOL Model SN6AT5 Device: AcrySof IQ Aspheric IOL AcrySof IQ aspheric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Other Name: AcrySof IQ Aspheric IOL Model SN60WF Procedure: Limbal Relaxing Incision (LRI) An incision was made at the corneal-limbal junction during cataract surgery for the purpose of relaxing corneal curvature, ie., correcting astigmatism.
Study Arm (s)	Experimental: IQ Toric IOL AcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation. Intervention: Device: AcrySof IQ Toric IOL Active Comparator: IQ Aspheric IOL + LRI AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation Interventions: Device: AcrySof IQ Aspheric IOL Procedure: Limbal Relaxing Incision (LRI)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	70
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Ocular criteria must be met in both eyes. Willing and able to understand and sign an informed consent; Willing and able to attend postoperative examinations per protocol schedule; Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure; Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts; Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes; Have the second surgery at least one week following the first eye implant but not later than one month after the first implant. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Previous corneal surgery; Planned multiple procedures during cataract/IOL implantation surgery; Ocular disease and/or condition that may compromise study results; Pregnant or planning pregnancy during course of study; Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01045733
Other Study ID Numbers ^ICMJE	M-09-045
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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