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

NCT ID: NCT01267500

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2017-10-31

Brief Summary

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

Detailed Description

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Conditions

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Intermittent Exotropia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-surgical therapy

patching or fusion exercises

Group Type EXPERIMENTAL

Non surgical therapy

Intervention Type PROCEDURE

patching or fusion exercises

Interventions

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Non surgical therapy

patching or fusion exercises

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Singapore National Eye Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Audrey Chia Wei-Lin

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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audrey chia

Role: PRINCIPAL_INVESTIGATOR

Singapore National Eye Center

Locations

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SIngapore National Eye Centre

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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R765/49/2010

Identifier Type: -

Identifier Source: org_study_id

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