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A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients

Primary Purpose

Cataracts

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring Intraocular lens, Multifocal intraocular lens (MIOL)

Eligibility Criteria

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

Inclusion Criteria:

  • Willing and able to understand and sign informed consent, and attend postoperative examinations per protocol schedule;
  • Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes;
  • Willing to have second eye surgery within 45 days of first eye surgery;
  • Expected postoperative astigmatism < 1.0 D in both eyes, as measured by keratometry;
  • Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement;
  • Significant irregular corneal astigmatism as demonstrated by corneal topography;
  • Severe degenerative visual disorders;
  • Previous corneal surgery;
  • Amblyopia;
  • Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study;
  • History of corneal disease;
  • Severe diabetic retinopathy;
  • History of retinal detachment;
  • Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study;
  • Pregnant or planning pregnancy during course of study;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bilateral

    Contralateral

    Arm Description

    AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation

    AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation

    Outcomes

    Primary Outcome Measures

    Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
    Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

    Secondary Outcome Measures

    Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)
    VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

    Full Information

    First Posted
    September 10, 2012
    Last Updated
    May 26, 2015
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01684007
    Brief Title
    A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients
    Official Title
    Clinical Outcomes After Implantation of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (MIOL) in the Dominant Eye and Randomization of the AcrySof® IQ ReSTOR® +2.5 D or +3.0 D MIOL in the Fellow Eye
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    August 2013 (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 is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye surgery.
    Detailed Description
    Each subject will complete a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second implantation will occur between 1 and 45 days of the first. If the first eye is not implanted during surgery, the second eye is not eligible. lf both eyes are not implanted with the assigned IOL, the subject will be followed for safety evaluation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataracts
    Keywords
    Intraocular lens, Multifocal intraocular lens (MIOL)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Bilateral
    Arm Type
    Experimental
    Arm Description
    AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
    Arm Title
    Contralateral
    Arm Type
    Active Comparator
    Arm Description
    AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation
    Intervention Type
    Device
    Intervention Name(s)
    AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
    Intervention Description
    Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
    Intervention Type
    Device
    Intervention Name(s)
    AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
    Intervention Description
    Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
    Primary Outcome Measure Information:
    Title
    Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
    Description
    Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
    Time Frame
    Day 90 from second eye implantation
    Secondary Outcome Measure Information:
    Title
    Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)
    Description
    VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
    Time Frame
    Day 90 from second eye implantation

    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 informed consent, and attend postoperative examinations per protocol schedule; Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes; Willing to have second eye surgery within 45 days of first eye surgery; Expected postoperative astigmatism < 1.0 D in both eyes, as measured by keratometry; Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement; Significant irregular corneal astigmatism as demonstrated by corneal topography; Severe degenerative visual disorders; Previous corneal surgery; Amblyopia; Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study; History of corneal disease; Severe diabetic retinopathy; History of retinal detachment; Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study; Pregnant or planning pregnancy during course of study; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Magda Michna, PhD
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients

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