Clinical trial NCT03700632: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Exotropia
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the experimental group will be treated with part time patch therapy and control group will be observed without any treatment.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 3-point scale Deviation Control
timeFrame: 3 months after treatment
measure: 3-point scale Deviation Control
timeFrame: 6 months after treatent
measure: 6-point scale Deviation Control
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Near stereopsis
timeFrame: at the time of enrollment, 3 month later and 6 month later
measure: Fusion
timeFrame: at the time of enrollment, 3 month later and 6 month later
Other outcomes:
Locations:
Study officials:
affiliation: Farabi Eye Research Center, Tehran University of Medical Sciences
name: Mohammad Reza Akbari, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Akbari MR, Mehrpour M, Mirmohammadsadeghi A. The influence of alternate part-time patching on control of intermittent exotropia: a randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2021 Jun;259(6):1625-1633. doi: 10.1007/s00417-020-05065-0. Epub 2021 Jan 7.