TerminatedNot Applicable

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

Stopped: Difficulty to keep children in randomly assigned groups.

Singapore60 participantsStarted 2010-10

Plain-language summary

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

Who can participate

Age range

3 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Control of strabismus

Timeframe: 1 year

Trial details

NCT IDNCT01267500

SponsorSingapore National Eye Centre

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Intermittent Exotropia trials

Who can participate

Age range

3 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria