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

This study has been terminated.
(Difficulty to keep children in randomly assigned groups.)
Information provided by (Responsible Party):
Audrey Chia Wei-Lin, Singapore National Eye Centre Identifier:
First received: December 27, 2010
Last updated: November 23, 2015
Last verified: November 2014
Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus

Condition Intervention Phase
Intermittent Exotropia
Procedure: Non surgical therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia

Resource links provided by NLM:

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • Control of strabismus [ Time Frame: 1 year ]

Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-surgical therapy
patching or fusion exercises
Procedure: Non surgical therapy
patching or fusion exercises


Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01267500

SIngapore National Eye Centre
SIngapore, Singapore
Sponsors and Collaborators
Singapore National Eye Centre
Principal Investigator: audrey chia Singapore National Eye Center
  More Information

Responsible Party: Audrey Chia Wei-Lin, Senior Consultant, Singapore National Eye Centre Identifier: NCT01267500     History of Changes
Other Study ID Numbers: R765/49/2010
Study First Received: December 27, 2010
Last Updated: November 23, 2015

Additional relevant MeSH terms:
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases processed this record on May 22, 2017