Intermittent ExotropiaNCT01267500
Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
A study testing Non surgical therapy in people with Intermittent Exotropia, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- Non surgical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2010to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus
- Conditions
- Intermittent Exotropia
- Being tested
- Non surgical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical therapyProcedure or surgery
patching or fusion exercises
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical therapy | Experimental | patching or fusion exercises Receives: Procedure: Non surgical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of strabismus
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Difficulty to keep children in randomly assigned groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Audrey Chia Wei-Lin, Singapore National Eye Centre
- Investigators
- audrey chia, Principal investigator, Singapore National Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267500
- Sponsor's protocol ID
- R765/49/2010
- Status last verified
- Mar 2023
- First submitted
- 27 Dec 2010
- Last updated
- 20 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT01267500
- Acronym / sponsor ID
- R765/49/2010
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty to keep children in randomly assigned groups.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Oct 2010 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 28 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-surgical therapy | Experimental | Procedure: Non surgical therapypatching or fusion exercises |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non surgical therapypatching or fusion exercises | Procedure or surgery | Non-surgical therapy |
Primary outcome
Control of strabismus
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Difficulty to keep children in randomly assigned groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
audrey chia principal investigator
Singapore National Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical therapy in people with Intermittent Exotropia, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty to keep children in randomly assigned groups.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of strabismus (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.