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

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ClinicalTrials.gov Identifier: NCT01267500
Recruitment Status : Terminated (Difficulty to keep children in randomly assigned groups.)
First Posted : December 28, 2010
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Audrey Chia Wei-Lin, Singapore National Eye Centre

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

Condition or disease Intervention/treatment Phase
Intermittent Exotropia Procedure: Non surgical therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
Study Start Date : October 2010
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017


Arm Intervention/treatment
Experimental: Non-surgical therapy
patching or fusion exercises
Procedure: Non surgical therapy
patching or fusion exercises



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


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267500


Locations
Singapore
SIngapore National Eye Centre
SIngapore, Singapore
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: audrey chia Singapore National Eye Center

Responsible Party: Audrey Chia Wei-Lin, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01267500     History of Changes
Other Study ID Numbers: R765/49/2010
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2014

Additional relevant MeSH terms:
Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases