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TerminatedNCT01267500Updated Mar 20, 2023

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

An interventional study of Non surgical therapy in Intermittent Exotropia, sponsored by Singapore National Eye Centre. Terminated at 1 site in Singapore. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by Singapore National Eye Centre · Not applicable, Interventional, and Treatment

Why this study was terminated
Difficulty to keep children in randomly assigned groups.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
3 Years to 12 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Intermittent Exotropia

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03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

Singapore National Eye Centre is the lead sponsor of 87 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Non-surgical therapy

    patching or fusion exercises

    Procedure: Non surgical therapy

Interventions

  • ProcedureNon surgical therapy

    patching or fusion exercises

06

What researchers measure

Primary outcomes

  1. Control of strabismus

    Time frame: 1 year

07

Study locations

1 site
  • SIngapore National Eye Centre
    SIngapore, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01267500
Lead sponsor
Singapore National Eye Centre
Responsible party
Audrey Chia Wei-Lin (Senior Consultant, Singapore National Eye Centre) — Principal investigator
First posted
Dec 28, 2010
Start date
Oct 2010
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Mar 20, 2023

Study contacts

audrey chia
principal investigator · Singapore National Eye Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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