TerminatedNot Applicable

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

Stopped: Difficulty to keep children in randomly assigned groups.

Singapore60 participantsStarted 2010-10

Plain-language summary

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

Age range3 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Control of strabismus

Timeframe: 1 year

NCT IDNCT01267500

SponsorSingapore National Eye Centre

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-10