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Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Monofocal IOL
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

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 as per protocol schedule;
  • Diagnosis of bilateral, age-related cataracts;
  • Planned cataract removal via phacoemulsification with implantation of an IOL;
  • Available to undergo second eye surgery within 6 weeks of the first eye surgery;
  • Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
  • No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
  • Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
  • Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Previous corneal surgery and/or reshaping;
  • Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
  • Planned multiple procedures during cataract/IOL implantation surgery;
  • Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
  • Pregnant, lactating, or planning pregnancy during the course of study;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    ReSTOR +3

    ReSTOR +3 Toric

    Monofocal

    Arm Description

    AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation

    AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye

    Monofocal IOL, bilateral implantation

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Classified as Responders
    Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.
    Proportion of Participants Reporting Spectacle Independence at All Distances
    Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.
    Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)
    Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.

    Secondary Outcome Measures

    Median Total Spectacle Cost Prior to Any Reimbursement
    Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.

    Full Information

    First Posted
    February 3, 2011
    Last Updated
    May 31, 2018
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01290068
    Brief Title
    Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
    Official Title
    Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 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 is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
    Detailed Description
    This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    ReSTOR +3
    Arm Type
    Experimental
    Arm Description
    AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation
    Arm Title
    ReSTOR +3 Toric
    Arm Type
    Experimental
    Arm Description
    AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye
    Arm Title
    Monofocal
    Arm Type
    Active Comparator
    Arm Description
    Monofocal IOL, bilateral implantation
    Intervention Type
    Device
    Intervention Name(s)
    AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
    Other Intervention Name(s)
    SN6AD1
    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 Toric IOL
    Other Intervention Name(s)
    SND1T2, SND1T3, SND1T4, SND1T5
    Intervention Description
    Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
    Intervention Type
    Device
    Intervention Name(s)
    Monofocal IOL
    Intervention Description
    Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Classified as Responders
    Description
    Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.
    Time Frame
    Month 6 after second eye implantation
    Title
    Proportion of Participants Reporting Spectacle Independence at All Distances
    Description
    Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.
    Time Frame
    Month 6 after second eye implantation
    Title
    Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)
    Description
    Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.
    Time Frame
    Month 6 after second eye implantation
    Secondary Outcome Measure Information:
    Title
    Median Total Spectacle Cost Prior to Any Reimbursement
    Description
    Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.
    Time Frame
    Month 6 after 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 an Informed Consent; Willing and able to attend post-operative examinations as per protocol schedule; Diagnosis of bilateral, age-related cataracts; Planned cataract removal via phacoemulsification with implantation of an IOL; Available to undergo second eye surgery within 6 weeks of the first eye surgery; Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts; No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D; Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator; Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Previous corneal surgery and/or reshaping; Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL; Planned multiple procedures during cataract/IOL implantation surgery; Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study; Pregnant, lactating, or planning pregnancy during the course of study; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brand Lead, Surgical, Global Medical Affairs
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses

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