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

Moderate Intermittent Exotropia Clinical Trial

— SOMIX  

Official title:

Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02736526
• Other study ID #: ZX201304
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Sun Yat-sen University
• Contact: Tao Shen, M.D.
• Phone: 86-13824449536
• Email: shentao[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exotropia
• Moderate Intermittent Exotropia

Intervention

Procedure:
• recession or resection of the horizontal extraocular muscles

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular alignment (Prism alternative cover test)		5 years
Primary	Binocular stereopsis at distance and near (Random dot stereopsis test)		5 years
Secondary	Newcastle control scores		5 years
Secondary	The intermittent exotropia questionnaire		5 years