Study of Surgical Treatment Versus Observation in Children With Moderate Intermittent Exotropia
NCT ID: NCT02736526
Last Updated: 2021-12-22
Study Results
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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UNKNOWN
NA
280 participants
INTERVENTIONAL
2015-11-30
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgical treatment
The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial.
recession or resection of the horizontal extraocular muscles
Observation only
No interventions assigned to this group
Interventions
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recession or resection of the horizontal extraocular muscles
Eligibility Criteria
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Inclusion Criteria
2. Simultaneous perception and fusion point in synoptophore, but no normal function of fusion and stereopsis.
3. Age at from 5 to 18 years, sex unlimited.
4. No treatment for IXT previously (including surgical and non-surgical treatment).
5. No amblyopia.
6. Signed informed consent form voluntarily.
Exclusion Criteria
2. Accompanied with systemic diseases (e.g. nervous system disease).
3. Unable to regular follow-up (e.g. from countryside and outlying district).
4. Investigators concluded that should be excluded.
5 Years
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Tao Shen
M. D., Principal Investigator
Locations
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jianhua Yan, M.D.
Role: primary
References
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Shen T, Chen J, Kang Y, Deng D, Lin X, Wu H, Li J, Wang Z, Qiu X, Jin L, Yan J. Surgical treatment versus observation in moderate intermittent exotropia (SOMIX): study protocol for a randomized controlled trial. Trials. 2023 Mar 1;24(1):153. doi: 10.1186/s13063-023-07189-0.
Other Identifiers
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ZX201304
Identifier Type: -
Identifier Source: org_study_id