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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01267500
Enrollment
60
Registered
2010-12-28
Start date
2010-10-31
Completion date
2017-10-31
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Exotropia

Brief summary

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

Interventions

patching or fusion exercises

Sponsors

Singapore National Eye Centre
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
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.

Design outcomes

Primary

MeasureTime frame
Control of strabismus1 year

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026