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Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia

Primary Purpose

Intermittent Exotropia

Status
Terminated
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Non surgical therapy
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 3 to 12 years (inclusive)
  2. IXT for distance or constant IXT for distance and either IXT or exophoria for near
  3. IXT size of > 10PD
  4. Visual acuity in worse eye of at least 0.3 logMar (Snellen 6/12)
  5. Visual acuity of no greater than 2 lines between eyes
  6. Parents or guardian willing to accept randomization, and to continue with observation or treatment for at least 6-12 months, unless deterioration of strabismus or fall in best corrected visual acuity of worse than 0.3logMar (Snellen 6/12) in either eye
  7. Investigator willing to observe IXT untreated for at least 1 year

Exclusion Criteria:

  1. Previous non-surgical treatment for IXT, or patch treatment for amblyopia within the last year
  2. Prior strabismus, intraocular or refractive surgery or botulinium injection
  3. Surgery planned within the next year
  4. Prematurity (birth weight < 1500g, gestational age < 34 weeks), systemic illness (eg. cerebral palsy), syndrome (including craniosynostosis) or learning disability
  5. Any ocular abnormality (cornea, lens or central retina); nystagmus or conditions that limit eye movements.

Sites / Locations

  • SIngapore National Eye Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-surgical therapy

Arm Description

patching or fusion exercises

Outcomes

Primary Outcome Measures

Control of strabismus

Secondary Outcome Measures

Full Information

First Posted
December 27, 2010
Last Updated
March 15, 2023
Sponsor
Singapore National Eye Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01267500
Brief Title
Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
Official Title
Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty to keep children in randomly assigned groups.
Study Start Date
October 2010 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore National Eye Centre

4. Oversight

5. Study Description

Brief Summary
Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-surgical therapy
Arm Type
Experimental
Arm Description
patching or fusion exercises
Intervention Type
Procedure
Intervention Name(s)
Non surgical therapy
Intervention Description
patching or fusion exercises
Primary Outcome Measure Information:
Title
Control of strabismus
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 3 to 12 years (inclusive) IXT for distance or constant IXT for distance and either IXT or exophoria for near IXT size of > 10PD Visual acuity in worse eye of at least 0.3 logMar (Snellen 6/12) Visual acuity of no greater than 2 lines between eyes Parents or guardian willing to accept randomization, and to continue with observation or treatment for at least 6-12 months, unless deterioration of strabismus or fall in best corrected visual acuity of worse than 0.3logMar (Snellen 6/12) in either eye Investigator willing to observe IXT untreated for at least 1 year Exclusion Criteria: Previous non-surgical treatment for IXT, or patch treatment for amblyopia within the last year Prior strabismus, intraocular or refractive surgery or botulinium injection Surgery planned within the next year Prematurity (birth weight < 1500g, gestational age < 34 weeks), systemic illness (eg. cerebral palsy), syndrome (including craniosynostosis) or learning disability Any ocular abnormality (cornea, lens or central retina); nystagmus or conditions that limit eye movements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
audrey chia
Organizational Affiliation
Singapore National Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SIngapore National Eye Centre
City
SIngapore
Country
Singapore

12. IPD Sharing Statement

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Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia

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