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

• Sponsor: Singapore National Eye Centre (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01267500
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 84
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intermittent Exotropia	Procedure: Non surgical therapy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
• Study Start Date: Oct 1, 2010
• Anticipated Primary Completion Date: Oct 1, 2017
• Anticipated Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-surgical therapy patching or fusion exercises	Procedure: Non surgical therapy; patching or fusion exercises

Outcome Measures

Primary Outcome Measures

1. Control of strabismus [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SIngapore National Eye Centre	SIngapore		Singapore

Sponsors and Collaborators

• Singapore National Eye Centre

Investigators

• Principal Investigator: audrey chia, Singapore National Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Audrey Chia Wei-Lin, Senior Consultant, Singapore National Eye Centre
• ClinicalTrials.gov Identifier: NCT01267500
• Other Study ID Numbers: R765/49/2010
• First Posted: Dec 28, 2010
• Last Update Posted: Nov 24, 2015
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Exotropia

Study Results

No Results Posted as of Nov 24, 2015