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Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

Primary Purpose

Asthenopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ophthalmic lens with extra power
Sponsored by
Essilor International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthenopia

Eligibility Criteria

20 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjective report of visual fatigue
  • Non-presbyopes
  • Permanent wearers who wear glasses for at least 5 hours a day
  • Distance refractive error within the range of [+6.00 to -6.00]* (with cylinder in the negative form),
  • Cylindrical component of the refractive error within the range of 0 to 2 D in both eyes,
  • Anisometropia ≤ 1.00 D in sperical equivalent,
  • Visual acuity of +0.10 logMAR or better in each eye with new prescription at distance (high contrast/high luminance),
  • Distance visual acuity difference ≤0.20 logMAR between right and left eye (high contrast, high luminance)
  • Near binocular visual acuity of +0.10 logMAR or better with a new prescription (high contrast, high luminance),
  • Study frame characteristics: Frame B size at least 22 mm

Exclusion Criteria:

  • Vulnerability of the subject,
  • Participation in another study which might have an influence on vision or interfere with study assessments,
  • Binocular vision problems,
  • Known ocular pathology (e.g., age-related macular degeneration, glaucoma…),
  • Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g., iridectomy, refractive surgery…),
  • Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g., uncontrolled diabetes, uncontrolled high blood pressure…),
  • Any medical treatment or medication that might have an influence on vision or interfere with study assessments (e.g., antidepressants, drugs with atropinic effects…),
  • Knowledge/expertise in optometry, ophthalmic lenses, or optics based on past or current professional activity (e.g., optometrists, opticians, ophthalmologists…)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    20-29 years (+0.40D extra power)

    30-35 years (+0.40D extra power)

    20-29 years (+0.40D extra power with blue cut)

    Arm Description

    Outcomes

    Primary Outcome Measures

    The difference in number of participants with treatment-related adverse events between the two lenses
    Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Determined by subject's spontaneous reporting, the Investigator's non-leading questioning and his/her evaluation.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2021
    Last Updated
    October 10, 2021
    Sponsor
    Essilor International
    Collaborators
    Elite School of Optometry and Sankara Nethralaya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05089240
    Brief Title
    Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power
    Official Title
    Data Collection of Objective Parameters and Subjective Feedback on Visually Fatigued Subjects and Evaluation of the Effect of Ophthalmic Lenses to Alleviate Visual Fatigue
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 6, 2016 (Actual)
    Primary Completion Date
    December 2, 2016 (Actual)
    Study Completion Date
    July 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Essilor International
    Collaborators
    Elite School of Optometry and Sankara Nethralaya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate subjective visual performance and objective visual parameters when wearing ophthalmic lenses with extra power (+0.4 D or +0.6 D), and ophthalmic lenses with a selective blue cut filter.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    127 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    20-29 years (+0.40D extra power)
    Arm Type
    Other
    Arm Title
    30-35 years (+0.40D extra power)
    Arm Type
    Other
    Arm Title
    20-29 years (+0.40D extra power with blue cut)
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Ophthalmic lens with extra power
    Primary Outcome Measure Information:
    Title
    The difference in number of participants with treatment-related adverse events between the two lenses
    Description
    Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Determined by subject's spontaneous reporting, the Investigator's non-leading questioning and his/her evaluation.
    Time Frame
    Immediately after the first and second wearing period (21 days each)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjective report of visual fatigue Non-presbyopes Permanent wearers who wear glasses for at least 5 hours a day Distance refractive error within the range of [+6.00 to -6.00]* (with cylinder in the negative form), Cylindrical component of the refractive error within the range of 0 to 2 D in both eyes, Anisometropia ≤ 1.00 D in sperical equivalent, Visual acuity of +0.10 logMAR or better in each eye with new prescription at distance (high contrast/high luminance), Distance visual acuity difference ≤0.20 logMAR between right and left eye (high contrast, high luminance) Near binocular visual acuity of +0.10 logMAR or better with a new prescription (high contrast, high luminance), Study frame characteristics: Frame B size at least 22 mm Exclusion Criteria: Vulnerability of the subject, Participation in another study which might have an influence on vision or interfere with study assessments, Binocular vision problems, Known ocular pathology (e.g., age-related macular degeneration, glaucoma…), Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g., iridectomy, refractive surgery…), Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g., uncontrolled diabetes, uncontrolled high blood pressure…), Any medical treatment or medication that might have an influence on vision or interfere with study assessments (e.g., antidepressants, drugs with atropinic effects…), Knowledge/expertise in optometry, ophthalmic lenses, or optics based on past or current professional activity (e.g., optometrists, opticians, ophthalmologists…)

    12. IPD Sharing Statement

    Learn more about this trial

    Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

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