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A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01225926
First received: October 20, 2010
Last updated: September 24, 2013
Last verified: September 2013

October 20, 2010
September 24, 2013
March 2011
June 2012   (final data collection date for primary outcome measure)
Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
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.
  • Uncorrected Distance Visual Acuity [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
  • Subject satisfaction [ Time Frame: 3 months afer surgery ] [ Designated as safety issue: No ]
    Subject satisfaction as measured by subject questionnaire
Complete list of historical versions of study NCT01225926 on ClinicalTrials.gov Archive Site
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A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cataract
  • 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
  • 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
  • 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.
    Intervention: Device: Toric T3 - T9
  • 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.
    Intervention: Device: IQ SN60WF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to understand and sign an informed consent;
  • Willing and able to attend post-operative examinations per protocol schedule;
  • In good ocular health, with the exception of cataracts;
  • Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
  • Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
  • In good ocular health, with the exception of cataracts;
  • Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Previous corneal surgery;
  • Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
  • Planned multiple procedures during cataract/IOL implantation surgery;
  • Ocular disease and/or condition that may compromise study results;
  • Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
  • Pregnant or planning pregnancy during course of study;
  • Participation in any other investigational study within 30 days prior to enrolment;
  • Other protocol-defined exclusion criteria may apply.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01225926
M10-003
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
September 2013

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