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

Not Applicable

Completed

• Conditions: Cataract; Astigmatism
• Interventions: Device: AcrySof IQ Toric IOL; Device: AcrySof IQ Aspheric IOL; Procedure: Limbal Relaxing Incision (LRI)

• Registration Number: NCT01045733
• Lead Sponsor: Alcon Research

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IQ Toric IOL	AcrySof 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.
IQ Aspheric IOL + LRI	AcrySof IQ Aspheric IOL	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
IQ Aspheric IOL + LRI	Limbal Relaxing Incision (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

Primary Outcome Measures

Name	Time	Method
Corneal Aberration	Month 6 postoperative

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	Month 6 postoperative
Corneal Cylinder	6 months

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States