- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02736526
Study of Surgical Treatment Versus Observation in Children With Moderate Intermittent Exotropia (SOMIX)
December 21, 2021 updated by: Tao Shen, Sun Yat-sen University
Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia
The purpose of this study is to determine the long-term effect and security of the surgical treatment and observation only on ocular alignment, binocular stereopsis, and quality of life in children with moderate intermittent exotropia.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
280
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 Contact
- Name: Tao Shen, M.D.
- Phone Number: 86-13824449536
- Email: shentao@mail2.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Zhongshan Ophthalmic Center, Sun Yat-sen University
-
Contact:
- Jianhua Yan, M.D.
- Phone Number: 86-18922103805
- Email: yan2011@tom.com
-
-
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
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To correspond the definition of IXT: monocular or binocular alternative exotropia, exodeviation at distance for 15 prism diopters at least, can control the normal ocular alignment, normal ocular movements.
- Simultaneous perception and fusion point in synoptophore, but no normal function of fusion and stereopsis.
- Age at from 5 to 18 years, sex unlimited.
- No treatment for IXT previously (including surgical and non-surgical treatment).
- No amblyopia.
- Signed informed consent form voluntarily.
Exclusion Criteria:
- Accompanied with ocular organic diseases.
- Accompanied with systemic diseases (e.g. nervous system disease).
- Unable to regular follow-up (e.g. from countryside and outlying district).
- Investigators concluded that should be excluded.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgical treatment
The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial.
|
|
No Intervention: Observation only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ocular alignment (Prism alternative cover test)
Time Frame: 5 years
|
5 years
|
Binocular stereopsis at distance and near (Random dot stereopsis test)
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Newcastle control scores
Time Frame: 5 years
|
5 years
|
The intermittent exotropia questionnaire
Time Frame: 5 years
|
5 years
|
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)
November 1, 2015
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
April 3, 2016
First Submitted That Met QC Criteria
April 7, 2016
First Posted (Estimate)
April 13, 2016
Study Record Updates
Last Update Posted (Actual)
December 22, 2021
Last Update Submitted That Met QC Criteria
December 21, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZX201304
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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-
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