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Effect of Blue Light Filtration on Visual Performance

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clear clip-on glasses
Blue light filter clip-on glasses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cataract focused on measuring cataract, intraocular lens, IOL, blue light filter

Eligibility Criteria

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

Inclusion Criteria:

  • Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months;
  • Good ocular health;
  • 20/40 or better vision with best correction in both eyes;
  • Willing to provide voluntary consent and sign informed consent form;
  • Able to competently perform testing;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Clear, then Blue Light Filter

    Blue Light Filter, then Clear

    Arm Description

    Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction

    Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction

    Outcomes

    Primary Outcome Measures

    Photostress Recovery Time
    Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 3, 2013
    Last Updated
    January 14, 2015
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01938989
    Brief Title
    Effect of Blue Light Filtration on Visual Performance
    Official Title
    Effect of Blue Light Filtration on Visual Performance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (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 evaluate photostress recovery with blue light filter clip-on glasses among pseudophakes [ie, subjects in which the natural lens of the eye has been replaced with an artificial lens (intraocular lens) during cataract surgery]. This study will enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for at least 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    cataract, intraocular lens, IOL, blue light filter

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    158 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clear, then Blue Light Filter
    Arm Type
    Other
    Arm Description
    Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
    Arm Title
    Blue Light Filter, then Clear
    Arm Type
    Other
    Arm Description
    Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
    Intervention Type
    Device
    Intervention Name(s)
    Clear clip-on glasses
    Intervention Description
    Clip-on glasses with no light filtering properties
    Intervention Type
    Device
    Intervention Name(s)
    Blue light filter clip-on glasses
    Intervention Description
    Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs
    Primary Outcome Measure Information:
    Title
    Photostress Recovery Time
    Description
    Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months; Good ocular health; 20/40 or better vision with best correction in both eyes; Willing to provide voluntary consent and sign informed consent form; Able to competently perform testing; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stefani Smith, MS
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Blue Light Filtration on Visual Performance

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