search
Back to results

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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Toric T3 - T9
IQ SN60WF
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, Toric

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Toric T3 - T9

    IQ SN60WF

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at 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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 20, 2010
    Last Updated
    September 24, 2013
    Sponsor
    Alcon Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01225926
    Brief Title
    A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    Intraocular Lens, Toric

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Toric T3 - T9
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    IQ SN60WF
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Device
    Intervention Name(s)
    Toric T3 - T9
    Other Intervention Name(s)
    AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9
    Intervention Description
    Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient
    Intervention Type
    Device
    Intervention Name(s)
    IQ SN60WF
    Other Intervention Name(s)
    AcrySof® IQ IOL Model SN60WF
    Intervention Description
    Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient
    Primary Outcome Measure Information:
    Title
    Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3
    Description
    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.
    Time Frame
    Month 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs