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
About this trial
This is an interventional treatment trial for Intermittent Exotropia
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.
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
NCT ID
NCT03700632
First Posted
October 5, 2018
Last Updated
October 5, 2018
Sponsor
Tehran University of Medical Sciences
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
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Results Reference
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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
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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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.
Results Reference
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Citation
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Citation
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Results Reference
derived
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Part-time Patch Therapy for Treatment of Intermittent Exotropia
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