Part-time Patch Therapy for Treatment of Intermittent Exotropia

T

Tehran University of Medical Sciences

Status

Unknown

Conditions

Intermittent Exotropia

Treatments

Other: patch therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03700632
9611257005

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

3 to 8 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

64 participants in 2 patient groups

patch therapy
Experimental group
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.
Treatment:
Other: patch therapy
Control
No Intervention group
Description:
no intervention will be done

Trial contacts and locations

0

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Central trial contact

Mohammad Mehrpour, MD

Data sourced from clinicaltrials.gov

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