A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01045733|
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : November 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cataract Astigmatism||Device: AcrySof IQ Toric IOL Device: AcrySof IQ Aspheric IOL Procedure: Limbal Relaxing Incision (LRI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
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.
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.
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
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.
- Corneal Aberration [ Time Frame: Month 6 postoperative ]
- Visual Acuity [ Time Frame: Month 6 postoperative ]
- Corneal Cylinder [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045733
|United States, Texas|
|Contact Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|