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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
  Purpose

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: Parallel 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:

U.S. FDA Resources

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • Control of strabismus [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2010
Estimated Primary Completion Date: October 2016 (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

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267500

Contacts
Contact: Audrey Chia, FRANZCO audrey.chia.w.l@snec.com.sg

Locations
Singapore
SIngapore National Eye Centre Recruiting
SIngapore, Singapore
Contact: Audrey Chia         audrey.chia.w.l@snec.com.sg    
Sub-Investigator: sonal fazdavandi            
Sub-Investigator: Boon Long Quah            
Sub-Investigator: Yvonne Ling            
Sub-Investigator: Lam Pin Min            
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: audrey chia Singapore National Eye Center
  More Information

No publications provided

Responsible Party: Audrey Chia, Singapore National Eye Center
ClinicalTrials.gov Identifier: NCT01267500     History of Changes
Other Study ID Numbers: R765/49/2010
Study First Received: December 27, 2010
Last Updated: December 27, 2010
Health Authority: Singapore: Singhealth

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

ClinicalTrials.gov processed this record on June 18, 2013