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

Sun Yat-sen University

Status: Unknown

Conditions: Moderate Intermittent Exotropia

Treatments: Procedure: recession or resection of the horizontal extraocular muscles

Study type: Interventional

Funder types: Other

Identifiers

NCT02736526

ZX201304

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Surgical treatment

Experimental group

Description:

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

Treatment:

Procedure: recession or resection of the horizontal extraocular muscles

Observation only

No Intervention group