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Part-time Patch Therapy for Treatment of Intermittent Exotropia

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ClinicalTrials.gov Identifier: NCT03700632
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Intermittent Exotropia Other: patch therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: the experimental group will be treated with part time patch therapy and control group will be observed without any treatment.
Masking: Triple (Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : November 10, 2021

Arm Intervention/treatment
Experimental: patch therapy
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.
Other: patch therapy
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: Control
no intervention will be done



Primary Outcome Measures :
  1. 3-point scale Deviation Control [ Time Frame: 3 months after treatment ]

    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.


  2. 3-point scale Deviation Control [ Time Frame: 6 months after treatent ]

    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. 6-point scale Deviation Control [ Time Frame: 3 months after treatment ]

    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 :
  1. Near stereopsis [ Time Frame: at the time of enrollment, 3 month later and 6 month later ]
    Stereo acuity is measured at 40 cm using the Titmus test

  2. Fusion [ Time Frame: at the time of enrollment, 3 month later and 6 month later ]
    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.



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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700632


Contacts
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Contact: Mohammad Mehrpour, MD 00989125011468 m.mehrpur@gmail.com

Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Mohammad Reza Akbari, MD Farabi Eye Research Center, Tehran University of Medical Sciences
Publications:

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03700632    
Other Study ID Numbers: 9611257005
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases