- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267500
Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
March 15, 2023 updated by: Audrey Chia Wei-Lin, Singapore National Eye Centre
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
SIngapore, Singapore
- Singapore National Eye Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Non-surgical therapy
patching or fusion exercises
|
patching or fusion exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Control of strabismus
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2010
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
December 27, 2010
First Submitted That Met QC Criteria
December 27, 2010
First Posted (Estimate)
December 28, 2010
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 15, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R765/49/2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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