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Part-time Patch Therapy for Treatment of Intermittent Exotropia

Primary Purpose

Intermittent Exotropia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patch therapy
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Intermittent distance exotropia or constant distance exotropia at least 15Δ and intermittent near exotropia or exophoria

Exclusion Criteria:

  • No child's cooperation in evaluation of deviation control and regular visits for follow-up examinations
  • Anisometropia more than 1.50 D, hypermetropia more than 3.50 D, and myopia more than 4.50 D on cyclorefraction
  • History of previous treatments including eye occlusion, minus therapy, and strabismus surgery
  • Any eye and systemic diseases other than strabismus including neurologic diseases and developmental delay.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    patch therapy

    Control

    Arm Description

    The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week.

    no intervention will be done

    Outcomes

    Primary Outcome Measures

    3-point scale Deviation Control
    the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
    3-point scale Deviation Control
    the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
    6-point scale Deviation Control
    the ability of the child to control his/her deviation at far and near was assessed based on the office control 6-point scale: Children are classified according to the office control 6-point scale into six groups of 0 to 5. In this classification, exotropia is ranked after 30 seconds of observation: constant exotropia is ranked 5th, exotropia in more than 50% of the observing time is ranked 4th, and exotropia in less than 50% of the observing time is ranked 3rd. If exotropia is not seen in 30 seconds, the classification is made based on the speed of deviation control and fusion return 10 seconds after covering the eyes: back of fusion in more than 5 seconds is ranked 2nd, fusion return between 1 and 5 seconds ranked 1st, and fusion return in less than 1 second is ranked 0.

    Secondary Outcome Measures

    Near stereopsis
    Stereo acuity is measured at 40 cm using the Titmus test
    Fusion
    fusion at far & near are measured using the Worth 4-dot test. The Worth 4-dot test is used at 50 cm and 6 m for evaluating central and peripheral suppression.

    Full Information

    First Posted
    October 5, 2018
    Last Updated
    October 5, 2018
    Sponsor
    Tehran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03700632
    Brief Title
    Part-time Patch Therapy for Treatment of Intermittent Exotropia
    Official Title
    A Randomized Clinical Trial of Part-time Patching Therapy on Improvement of Deviation Control in 3 to 8 Year-old Children With Intermittent Exotropia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2018 (Anticipated)
    Primary Completion Date
    May 10, 2020 (Anticipated)
    Study Completion Date
    November 10, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tehran University of Medical Sciences

    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
    Intermittent exotropia is the most common type of exotropia in children. Treatment options are surgical and non surgical. Nonsurgical management include Correction of refractive errors, Active orthoptic treatments, Prisms and Occlusion therapy. Benefits of patch therapy are limiting suppression, reducing the frequency and amplitude of the deviation, changing the nature of the deviation (from constant to intermittent exotropia or from intermittent exotropia to exophoria), however, there is a concern that occlusion of the eyes may cause fusion failure and worsen deviation control. According to a few number of studies and controversy among the results of investigations, the investigators designed this randomized clinical trial study to determine the effect of partial patch therapy on the deviation control of children with intermittent exotropia.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    the experimental group will be treated with part time patch therapy and control group will be observed without any treatment.
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Masking Description
    care provider, investigator and outcome assessor will be unaware the group of participants. because of the nature of study, patch therapy vs no treatment, masking of participant will not be possible.
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patch therapy
    Arm Type
    Experimental
    Arm Description
    The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    no intervention will be done
    Intervention Type
    Other
    Intervention Name(s)
    patch therapy
    Intervention Description
    The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week
    Primary Outcome Measure Information:
    Title
    3-point scale Deviation Control
    Description
    the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
    Time Frame
    3 months after treatment
    Title
    3-point scale Deviation Control
    Description
    the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
    Time Frame
    6 months after treatent
    Title
    6-point scale Deviation Control
    Description
    the ability of the child to control his/her deviation at far and near was assessed based on the office control 6-point scale: Children are classified according to the office control 6-point scale into six groups of 0 to 5. In this classification, exotropia is ranked after 30 seconds of observation: constant exotropia is ranked 5th, exotropia in more than 50% of the observing time is ranked 4th, and exotropia in less than 50% of the observing time is ranked 3rd. If exotropia is not seen in 30 seconds, the classification is made based on the speed of deviation control and fusion return 10 seconds after covering the eyes: back of fusion in more than 5 seconds is ranked 2nd, fusion return between 1 and 5 seconds ranked 1st, and fusion return in less than 1 second is ranked 0.
    Time Frame
    3 months after treatment
    Secondary Outcome Measure Information:
    Title
    Near stereopsis
    Description
    Stereo acuity is measured at 40 cm using the Titmus test
    Time Frame
    at the time of enrollment, 3 month later and 6 month later
    Title
    Fusion
    Description
    fusion at far & near are measured using the Worth 4-dot test. The Worth 4-dot test is used at 50 cm and 6 m for evaluating central and peripheral suppression.
    Time Frame
    at the time of enrollment, 3 month later and 6 month later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Intermittent distance exotropia or constant distance exotropia at least 15Δ and intermittent near exotropia or exophoria Exclusion Criteria: No child's cooperation in evaluation of deviation control and regular visits for follow-up examinations Anisometropia more than 1.50 D, hypermetropia more than 3.50 D, and myopia more than 4.50 D on cyclorefraction History of previous treatments including eye occlusion, minus therapy, and strabismus surgery Any eye and systemic diseases other than strabismus including neurologic diseases and developmental delay.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammad Mehrpour, MD
    Phone
    00989125011468
    Email
    m.mehrpur@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Reza Akbari, MD
    Organizational Affiliation
    Farabi Eye Research Center, Tehran University of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12140202
    Citation
    Yu CB, Fan DS, Wong VW, Wong CY, Lam DS. Changing patterns of strabismus: a decade of experience in Hong Kong. Br J Ophthalmol. 2002 Aug;86(8):854-6. doi: 10.1136/bjo.86.8.854.
    Results Reference
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    Citation
    Multi-ethnic Pediatric Eye Disease Study Group. Prevalence of amblyopia and strabismus in African American and Hispanic children ages 6 to 72 months the multi-ethnic pediatric eye disease study. Ophthalmology. 2008 Jul;115(7):1229-1236.e1. doi: 10.1016/j.ophtha.2007.08.001. Epub 2007 Oct 22.
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    PubMed Identifier
    3506931
    Citation
    Vishnoi SK, Singh V, Mehra MK. Role of occlusion in treatment of intermittent exotropia. Indian J Ophthalmol. 1987 Jul-Aug;35(4):207-10. No abstract available.
    Results Reference
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    PubMed Identifier
    25234012
    Citation
    Pediatric Eye Disease Investigator Group; Cotter SA, Mohney BG, Chandler DL, Holmes JM, Repka MX, Melia M, Wallace DK, Beck RW, Birch EE, Kraker RT, Tamkins SM, Miller AM, Sala NA, Glaser SR. A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. Ophthalmology. 2014 Dec;121(12):2299-310. doi: 10.1016/j.ophtha.2014.07.021. Epub 2014 Sep 16.
    Results Reference
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    PubMed Identifier
    555806
    Citation
    Spoor DK, Hiles DA. Occlusion therapy for exodeviations occurring in infants and young children. Ophthalmology. 1979 Dec;86(12):2152-7. doi: 10.1016/s0161-6420(79)35295-2.
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    PubMed Identifier
    2709283
    Citation
    Freeman RS, Isenberg SJ. The use of part-time occlusion for early onset unilateral exotropia. J Pediatr Ophthalmol Strabismus. 1989 Mar-Apr;26(2):94-6. doi: 10.3928/0191-3913-19890301-14.
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    PubMed Identifier
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    Citation
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    PubMed Identifier
    14274107
    Citation
    IACOBUCCI I, HENDERSON JW. OCCLUSION IN THE PREOPERATIVE TREATMENT OF EXODEVIATIONS. Am Orthopt J. 1965;15:42-7. No abstract available.
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    PubMed Identifier
    16463040
    Citation
    Suh YW, Kim SH, Lee JY, Cho YA. Conversion of intermittent exotropia types subsequent to part-time occlusion therapy and its sustainability. Graefes Arch Clin Exp Ophthalmol. 2006 Jun;244(6):705-8. doi: 10.1007/s00417-005-0195-0. Epub 2006 Feb 4.
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    Citation
    AlKahmous LS, Al-Saleh AA. Does occlusion therapy improve control in intermittent exotropia? Saudi J Ophthalmol. 2016 Oct-Dec;30(4):240-243. doi: 10.1016/j.sjopt.2016.07.004. Epub 2016 Jul 25.
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    Results Reference
    derived

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    Part-time Patch Therapy for Treatment of Intermittent Exotropia

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