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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:

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:

  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.

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.
Procedure: recession or resection of the horizontal extraocular muscles
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

Sun Yat-sen University

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

Keywords

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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