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

NCT01267500 | Terminated

• 1 other identifier: R765/49/2010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (1)

• Control of strabismus

  1 year

Study Arms (1)

Non-surgical therapy

EXPERIMENTAL

patching or fusion exercises

Procedure: Non surgical therapy

Interventions

Non surgical therapy PROCEDURE

patching or fusion exercises

Non-surgical therapy

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 to 12 years (inclusive)
• IXT for distance or constant IXT for distance and either IXT or exophoria for near
• IXT size of \> 10PD
• Visual acuity in worse eye of at least 0.3 logMar (Snellen 6/12)
• Visual acuity of no greater than 2 lines between eyes
• 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
• Investigator willing to observe IXT untreated for at least 1 year

You may not qualify if:

• Previous non-surgical treatment for IXT, or patch treatment for amblyopia within the last year
• Prior strabismus, intraocular or refractive surgery or botulinium injection
• Surgery planned within the next year
• Prematurity (birth weight \< 1500g, gestational age \< 34 weeks), systemic illness (eg. cerebral palsy), syndrome (including craniosynostosis) or learning disability
• Any ocular abnormality (cornea, lens or central retina); nystagmus or conditions that limit eye movements.

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

SIngapore National Eye Centre

Singapore, Singapore

Location

Study Officials

• audrey chia

  Singapore National Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

SG (1)