Clinical Trial: Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2

Brief Summary: The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.

Detailed Summary: Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.
Sponsor: Alcon Research

Current Primary Outcome:

  • Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ]
    Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
  • Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 [ Time Frame: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation ]
    Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.
  • Photopic Contrast Sensitivity Without Glare at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ]
    Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be und

    Original Primary Outcome:

    Current Secondary Outcome:

    • Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ]
      VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
    • Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ]
      VA was tested monocularly (each eye separately) 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, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
    • Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ]
      Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?"
    • Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ]
      Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?"


    Original Secondary Outcome:

    Information By: Alcon Research

    Dates:
    Date Received: January 12, 2012
    Date Started: February 2012
    Date Completion:
    Last Updated: May 8, 2015
    Last Verified: May 2015