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

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: NCT01225926
Recruitment Status : Completed
First Posted : October 21, 2010
Results First Posted : September 24, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Device: Toric T3 - T9 Device: IQ SN60WF Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
Study Start Date : March 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 [ Time Frame: Month 3 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01225926    
Other Study ID Numbers: M10-003
First Posted: October 21, 2010    Key Record Dates
Results First Posted: September 24, 2013
Last Update Posted: October 29, 2013
Last Verified: September 2013
Keywords provided by Alcon Research:
Intraocular Lens
Toric
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases