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

This study is currently recruiting participants.
Verified October 2010 by Singapore National Eye Centre
Sponsor:
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01267500
First received: December 27, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

December 27, 2010
December 27, 2010
October 2010
October 2016   (final data collection date for primary outcome measure)
Control of strabismus [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Intermittent Exotropia
Procedure: Non surgical therapy
patching or fusion exercises
Experimental: Non-surgical therapy
patching or fusion exercises
Intervention: Procedure: Non surgical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
October 2016   (final data collection date for primary outcome measure)

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.
Both
3 Years to 12 Years
Yes
Contact: Audrey Chia, FRANZCO audrey.chia.w.l@snec.com.sg
Singapore
 
NCT01267500
R765/49/2010
Not Provided
Audrey Chia, Singapore National Eye Center
Singapore National Eye Centre
Not Provided
Principal Investigator: audrey chia Singapore National Eye Center
Singapore National Eye Centre
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP