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

Intermittent Exotropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01267500
• Other study ID #: R765/49/2010
• Status: Terminated
• Phase: N/A
• Start date: October 2010
• Est. completion date: October 2017

Study information

• Verified date: March 2023
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

Intervention

Procedure:
• Non surgical therapy
patching or fusion exercises

Locations

Country	Name	City	State
Singapore	SIngapore National Eye Centre	SIngapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore National Eye Centre

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of strabismus		1 year