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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate Intermittent Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical treatment

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

Group Type EXPERIMENTAL

recession or resection of the horizontal extraocular muscles

Intervention Type PROCEDURE

Observation only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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recession or resection of the horizontal extraocular muscles

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No