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Comperative Trial Between an Accommodative Iol and Monofocal Iol

Primary Purpose

CATARACT SURGERY

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acrysof
Acuity's AIOL
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CATARACT SURGERY

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 30 and 65
  • Required cataract operation in one or both eyes
  • BCVA potetial at least 20/30
  • Clear intraoccular media
  • Willing to participate in study as evidenced by signing a written Informed Consent

Exclusion Criteria:Main

  • Prior surgery at the selected eye
  • No light perception or poor potential for improvement
  • Phacodonesis and damaged zonules
  • Pupil size at least 6 mm.
  • History of uveitis
  • Macular disease decreasing vision below 20/30
  • Amblyopia
  • Axial length shorter than 21 mm and longer than 25 mm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Acrysof

    Acuity's AIOL

    Arm Description

    Routine monofocal IOL

    Accomodaing IOL

    Outcomes

    Primary Outcome Measures

    distance and near visual acuity

    Secondary Outcome Measures

    centration pco

    Full Information

    First Posted
    January 17, 2008
    Last Updated
    June 10, 2012
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00604305
    Brief Title
    Comperative Trial Between an Accommodative Iol and Monofocal Iol
    Official Title
    A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Company could not supply the accommodating intraocular lenses for the study
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    a comparison of two intraocular lenses in regard of accommodative power.
    Detailed Description
    A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CATARACT SURGERY

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acrysof
    Arm Type
    Active Comparator
    Arm Description
    Routine monofocal IOL
    Arm Title
    Acuity's AIOL
    Arm Type
    Active Comparator
    Arm Description
    Accomodaing IOL
    Intervention Type
    Device
    Intervention Name(s)
    Acrysof
    Intervention Description
    Monofocal IOL
    Intervention Type
    Device
    Intervention Name(s)
    Acuity's AIOL
    Intervention Description
    Accommodating IOL
    Primary Outcome Measure Information:
    Title
    distance and near visual acuity
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    centration pco
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 30 and 65 Required cataract operation in one or both eyes BCVA potetial at least 20/30 Clear intraoccular media Willing to participate in study as evidenced by signing a written Informed Consent Exclusion Criteria:Main Prior surgery at the selected eye No light perception or poor potential for improvement Phacodonesis and damaged zonules Pupil size at least 6 mm. History of uveitis Macular disease decreasing vision below 20/30 Amblyopia Axial length shorter than 21 mm and longer than 25 mm

    12. IPD Sharing Statement

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    Comperative Trial Between an Accommodative Iol and Monofocal Iol

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