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Clinical Evaluation of a Progressive Addition Lens (PAL)

Primary Purpose

Presbyopia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Progressive Addition Lens (Shamir PrimeIITM) Spectacles
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Progressive Addition Lens, Multifocal, Presbyopia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • An ability to comprehend and give an informed consent for participation in the trial
  • Presbyopia

Exclusion Criteria:

  • Concurrent participation in another clinical trial
  • Age<18
  • For female subjects: pregnancy \ planning a pregnancy \ lactating at the time of enrollment
  • Imbalanced diabetes \ high blood pressure \ thyroid disease
  • Infectious disease
  • Inability (cognitively) to comprehend the instructions given during the trial and to comply with them

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Horizontal Intermediate Visual Field
    Visual Acuity
    Horizontal Near Visual Field
    Field of comfortable reading on a computer screen
    Horizontal Far Visual Field

    Secondary Outcome Measures

    Subjective Evaluation of Visual Quality
    Overall Subjective Feedback

    Full Information

    First Posted
    September 14, 2011
    Last Updated
    March 14, 2013
    Sponsor
    Ziv Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01443585
    Brief Title
    Clinical Evaluation of a Progressive Addition Lens (PAL)
    Official Title
    Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    November 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ziv Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients. This evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Presbyopia
    Keywords
    Progressive Addition Lens, Multifocal, Presbyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Progressive Addition Lens (Shamir PrimeIITM) Spectacles
    Intervention Description
    A pair of progressive addition lenses manufactured according to the subject's personal prescription.
    Primary Outcome Measure Information:
    Title
    Horizontal Intermediate Visual Field
    Time Frame
    Baseline
    Title
    Visual Acuity
    Time Frame
    Baseline
    Title
    Horizontal Near Visual Field
    Time Frame
    Baseline
    Title
    Field of comfortable reading on a computer screen
    Time Frame
    Baseline
    Title
    Horizontal Far Visual Field
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Subjective Evaluation of Visual Quality
    Time Frame
    2-3 weeks
    Title
    Overall Subjective Feedback
    Time Frame
    2-3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: An ability to comprehend and give an informed consent for participation in the trial Presbyopia Exclusion Criteria: Concurrent participation in another clinical trial Age<18 For female subjects: pregnancy \ planning a pregnancy \ lactating at the time of enrollment Imbalanced diabetes \ high blood pressure \ thyroid disease Infectious disease Inability (cognitively) to comprehend the instructions given during the trial and to comply with them
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yosef Pikel, M.D
    Organizational Affiliation
    Ziv Medical Center, Zefat, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of a Progressive Addition Lens (PAL)

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