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

January 8, 2010
November 27, 2012
December 2009
May 2011   (final data collection date for primary outcome measure)
Corneal Aberration [ Time Frame: Month 6 postoperative ] [ Designated as safety issue: No ]
Corneal Aberration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01045733 on ClinicalTrials.gov Archive Site
  • Visual Acuity [ Time Frame: Month 6 postoperative ] [ Designated as safety issue: No ]
  • Corneal Cylinder [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Corneal Cylinder [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Cataract
  • Astigmatism
  • 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.
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01045733
M-09-045
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP