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

Not Applicable

Terminated

• Conditions: Intermittent Exotropia
• Interventions: Procedure: Non surgical therapy

• Registration Number: NCT01267500
• Lead Sponsor: Singapore National Eye Centre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-27
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-28
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-surgical therapy	Non surgical therapy	patching or fusion exercises

Primary Outcome Measures

Name	Time	Method
Control of strabismus	1 year

Trial Locations

Locations (1)

SIngapore National Eye Centre; 🇸🇬 SIngapore, Singapore