Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736526
Recruitment Status : Unknown
Verified April 2019 by Tao Shen, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tao Shen, Sun Yat-sen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Tao Shen, M.D. 86-13824449536 shentao@mail2.sysu.edu.cn

Locations
Layout table for location information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tao Shen, M. D., Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02736526    
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:
Layout table for MeSH terms
Exotropia
Strabismus
Ocular Motility Disorders
 Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases