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Efficacy of Over-glasses Patch Treatment for Amblyopia in Children : OPTA Study (OPTA)

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
over-glasses patch
Conventional patch
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. moderate amblyopia (logMAR visual acuity in the amblyopic eye 0.3 to 0.7 inclusive)
  2. logMAR visual acuity in the sound eye of 0.1 or better
  3. intereye acuity difference of larger or equal to 0.3 of logMAR visual acuity
  4. the presence of or a history of an amblyogenic factor meeting study-specified criteria for strabismus and/or anisometropia.

Exclusion Criteria:

  1. presence of an ocular cause for low vision
  2. myopia greater than -6.0 diopters (D) spherical equivalent in either eye
  3. prior intraocular or refractive surgery
  4. treatment for amblyopia (other than spectacle correction) within the 6 months prior to the enrollment
  5. Down syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional patch

    over-glasses patch

    Arm Description

    The patients were prescribed 2 hours of patching per day for the sound eye and the spectacles were to be worn full-time. Conventional patch is occlusion treatment sticker (Opticlude Eye Patch, 3M, Maplewood, MN, USA) with an adhesive material attached to the skin and serves to cover the eyes.

    the patients were prescribed 2 hours of patching per day for the sound eye and the spectacles were to be worn full-time. Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is made of fabric and covers the glasses, hence serves to cover the eyes.

    Outcomes

    Primary Outcome Measures

    Changes in visual acuity (logMAR)
    changes in best- corrected visual acuity between before treatment and after 17 weeks. Visual acuity is assessed using the Snellen chart. logMAR visual acuity ranges 0.0 to 3.0. logMAR visual acuity of 0.0 corresponds to 20/20. Lower scores represents better functioning.

    Secondary Outcome Measures

    amblyopia treatment index
    A modified version of ATI was provided to the parent(s) of all the enrolled minor patients as part of their follow-up visit with their child. The test consisted of 20 items, translated to Korean by one English language specialist and three ophthalmologists. The score from each question contributed to a sub-scale of the adverse effect (question numbers 2, 3, 4, 7, 8, 9, 13, and 16), compliance (question numbers 1, 5, 6a, 10 and 12), and social stigma (question numbers 11, 14 and 18). The questionnaires were scored on a 5-point Likert scale system, and the parent-provided questionnaire used a strength of agreement scale with responses of "strongly agree" (5), "agree" (4), "neither agree nor disagree" (3), "disagree" (2), "strongly disagree" (1), and "not applicable." In the test, the majority of items were negative statements, and therefore, a higher score indicated a higher negative impact or a higher burden. Reverse scoring was applied to the few items that were positive statements.
    the best corrected visual acuity
    best corrected visual acuity (logMAR) at 17 weeks Visual acuity is assessed using the Snellen chart. logMAR visual acuity ranges 0.0 to 3.0. logMAR visual acuity of 0.0 corresponds to 20/20. Lower scores represents better functioning.
    change of binocularity
    A binocularity index was determined with the use of the Worth 4 Dot test at near and the Titmus stereo test with a scale ranging from 0 to 4 with the following characteristics: 0, indicating complete suppression; 1, a moderate central suppression scotoma with peripheral fusion at near only indicated by fusion on the Worth 4 Dot test at near; 2, a small suppression scotoma and peripheral fusion indicated by fusion of the Titmus stereo fly; 3, moderate stereoacuity (100-400 arc seconds) on the stereo test animals (1 to 3 animals) and/or on the stereo test circles (1 to 5 circles); and 4, good stereoacuity (<80 arc seconds ) on the stereo test circles (6 to 9 circles).

    Full Information

    First Posted
    March 9, 2017
    Last Updated
    March 14, 2017
    Sponsor
    Pusan National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03080285
    Brief Title
    Efficacy of Over-glasses Patch Treatment for Amblyopia in Children : OPTA Study
    Acronym
    OPTA
    Official Title
    Efficacy of Over-glasses Patch Treatment for Amblyopia in Children :OPTA Study, A Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a study to investigate efficacy of over-glasses patch treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.
    Detailed Description
    In a randomized multi-center controlled clinical trial, children younger than 7 years with moderate amblyopia (visual acuity in the range of 20/40 to 20/100) would be included to receive treatment with either a conventional patch or an over-glasses patch. The patients will be prescribed 2 hours of patching per day for the sound eye. Best-corrected visual acuity (BCVA) and stereopsis will be investigated and ATI questionnaires be collected from parents at 5 weeks and 17 weeks after the initiation of treatment.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    107 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional patch
    Arm Type
    Active Comparator
    Arm Description
    The patients were prescribed 2 hours of patching per day for the sound eye and the spectacles were to be worn full-time. Conventional patch is occlusion treatment sticker (Opticlude Eye Patch, 3M, Maplewood, MN, USA) with an adhesive material attached to the skin and serves to cover the eyes.
    Arm Title
    over-glasses patch
    Arm Type
    Experimental
    Arm Description
    the patients were prescribed 2 hours of patching per day for the sound eye and the spectacles were to be worn full-time. Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is made of fabric and covers the glasses, hence serves to cover the eyes.
    Intervention Type
    Device
    Intervention Name(s)
    over-glasses patch
    Intervention Description
    Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional patch
    Intervention Description
    Conventional patch (Opticlude Eye Patch, 3M, Maplewood, MN, USA) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.
    Primary Outcome Measure Information:
    Title
    Changes in visual acuity (logMAR)
    Description
    changes in best- corrected visual acuity between before treatment and after 17 weeks. Visual acuity is assessed using the Snellen chart. logMAR visual acuity ranges 0.0 to 3.0. logMAR visual acuity of 0.0 corresponds to 20/20. Lower scores represents better functioning.
    Time Frame
    17 weeks
    Secondary Outcome Measure Information:
    Title
    amblyopia treatment index
    Description
    A modified version of ATI was provided to the parent(s) of all the enrolled minor patients as part of their follow-up visit with their child. The test consisted of 20 items, translated to Korean by one English language specialist and three ophthalmologists. The score from each question contributed to a sub-scale of the adverse effect (question numbers 2, 3, 4, 7, 8, 9, 13, and 16), compliance (question numbers 1, 5, 6a, 10 and 12), and social stigma (question numbers 11, 14 and 18). The questionnaires were scored on a 5-point Likert scale system, and the parent-provided questionnaire used a strength of agreement scale with responses of "strongly agree" (5), "agree" (4), "neither agree nor disagree" (3), "disagree" (2), "strongly disagree" (1), and "not applicable." In the test, the majority of items were negative statements, and therefore, a higher score indicated a higher negative impact or a higher burden. Reverse scoring was applied to the few items that were positive statements.
    Time Frame
    17 weeks
    Title
    the best corrected visual acuity
    Description
    best corrected visual acuity (logMAR) at 17 weeks Visual acuity is assessed using the Snellen chart. logMAR visual acuity ranges 0.0 to 3.0. logMAR visual acuity of 0.0 corresponds to 20/20. Lower scores represents better functioning.
    Time Frame
    17 weeks
    Title
    change of binocularity
    Description
    A binocularity index was determined with the use of the Worth 4 Dot test at near and the Titmus stereo test with a scale ranging from 0 to 4 with the following characteristics: 0, indicating complete suppression; 1, a moderate central suppression scotoma with peripheral fusion at near only indicated by fusion on the Worth 4 Dot test at near; 2, a small suppression scotoma and peripheral fusion indicated by fusion of the Titmus stereo fly; 3, moderate stereoacuity (100-400 arc seconds) on the stereo test animals (1 to 3 animals) and/or on the stereo test circles (1 to 5 circles); and 4, good stereoacuity (<80 arc seconds ) on the stereo test circles (6 to 9 circles).
    Time Frame
    17 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: moderate amblyopia (logMAR visual acuity in the amblyopic eye 0.3 to 0.7 inclusive) logMAR visual acuity in the sound eye of 0.1 or better intereye acuity difference of larger or equal to 0.3 of logMAR visual acuity the presence of or a history of an amblyogenic factor meeting study-specified criteria for strabismus and/or anisometropia. Exclusion Criteria: presence of an ocular cause for low vision myopia greater than -6.0 diopters (D) spherical equivalent in either eye prior intraocular or refractive surgery treatment for amblyopia (other than spectacle correction) within the 6 months prior to the enrollment Down syndrome
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hee young Choi, MD, PhD
    Organizational Affiliation
    Pusan National University hospotal
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15824215
    Citation
    Scheiman MM, Hertle RW, Beck RW, Edwards AR, Birch E, Cotter SA, Crouch ER Jr, Cruz OA, Davitt BV, Donahue S, Holmes JM, Lyon DW, Repka MX, Sala NA, Silbert DI, Suh DW, Tamkins SM; Pediatric Eye Disease Investigator Group. Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol. 2005 Apr;123(4):437-47. doi: 10.1001/archopht.123.4.437.
    Results Reference
    result
    PubMed Identifier
    10360300
    Citation
    Flynn JT, Schiffman J, Feuer W, Corona A. The therapy of amblyopia: an analysis of the results of amblyopia therapy utilizing the pooled data of published studies. Trans Am Ophthalmol Soc. 1998;96:431-50; discussion 450-3.
    Results Reference
    result
    PubMed Identifier
    23882695
    Citation
    Wallace MP, Stewart CE, Moseley MJ, Stephens DA, Fielder AR; Monitored Occlusion Treatment Amblyopia Study (MOTAS) Cooperatives; Randomized Occlusion Treatment Amblyopia Study (ROTAS) Cooperatives. Compliance with occlusion therapy for childhood amblyopia. Invest Ophthalmol Vis Sci. 2013 Sep 17;54(9):6158-66. doi: 10.1167/iovs.13-11861.
    Results Reference
    result

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    Efficacy of Over-glasses Patch Treatment for Amblyopia in Children : OPTA Study

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