Part-time Patch Therapy for Treatment of Intermittent Exotropia

October 5, 2018 updated by: Tehran University of Medical Sciences

A Randomized Clinical Trial of Part-time Patching Therapy on Improvement of Deviation Control in 3 to 8 Year-old Children With Intermittent Exotropia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after treatment
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.
6 months after treatent
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.
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the time of enrollment, 3 month later and 6 month later
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.
at the time of enrollment, 3 month later and 6 month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Reza Akbari, MD, Farabi Eye Research Center, Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

May 10, 2020

Study Completion (Anticipated)

November 10, 2021

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9611257005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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