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Study of Surgical Treatment Versus Observation in Children With Moderate Intermittent Exotropia (SOMIX)

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ClinicalTrials.gov Identifier: NCT02736526
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tao Shen, Sun Yat-sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate Intermittent Exotropia Procedure: recession or resection of the horizontal extraocular muscles Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia
Actual Study Start Date : November 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Surgical treatment
The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial.
Procedure: recession or resection of the horizontal extraocular muscles
No Intervention: Observation only



Primary Outcome Measures :
  1. Ocular alignment (Prism alternative cover test) [ Time Frame: 5 years ]
  2. Binocular stereopsis at distance and near (Random dot stereopsis test) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Newcastle control scores [ Time Frame: 5 years ]
  2. The intermittent exotropia questionnaire [ Time Frame: 5 years ]


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  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:

  1. Accompanied with ocular organic diseases.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736526


Contacts
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Contact: Tao Shen, M.D. 86-13824449536 shentao@mail2.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jianhua Yan, M.D.    86-18922103805    yan2011@tom.com   
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Tao Shen, M. D., Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02736526     History of Changes
Other Study ID Numbers: ZX201304
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Keywords provided by Tao Shen, Sun Yat-sen University:
moderate intermittent exotropia
surgical treatment
observation
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases