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

Primary Purpose

Moderate Intermittent Exotropia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
recession or resection of the horizontal extraocular muscles
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Intermittent Exotropia focused on measuring moderate intermittent exotropia, surgical treatment, observation

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical treatment

Observation only

Arm Description

The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial.

Outcomes

Primary Outcome Measures

Ocular alignment (Prism alternative cover test)
Binocular stereopsis at distance and near (Random dot stereopsis test)

Secondary Outcome Measures

Newcastle control scores
The intermittent exotropia questionnaire

Full Information

First Posted
April 3, 2016
Last Updated
December 21, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02736526
Brief Title
Study of Surgical Treatment Versus Observation in Children With Moderate Intermittent Exotropia
Acronym
SOMIX
Official Title
Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Intermittent Exotropia
Keywords
moderate intermittent exotropia, surgical treatment, observation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Experimental
Arm Description
The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial.
Arm Title
Observation only
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
recession or resection of the horizontal extraocular muscles
Primary Outcome Measure Information:
Title
Ocular alignment (Prism alternative cover test)
Time Frame
5 years
Title
Binocular stereopsis at distance and near (Random dot stereopsis test)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Newcastle control scores
Time Frame
5 years
Title
The intermittent exotropia questionnaire
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Shen, M.D.
Phone
86-13824449536
Email
shentao@mail2.sysu.edu.cn
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Yan, M.D.
Phone
86-18922103805
Email
yan2011@tom.com

12. IPD Sharing Statement

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

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