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

Not Applicable

• Conditions: Moderate Intermittent Exotropia
• Interventions: Procedure: recession or resection of the horizontal extraocular muscles

• Registration Number: NCT02736526
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-03
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment	recession or resection of the horizontal extraocular muscles	The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial.

Primary Outcome Measures

Name	Time	Method
Ocular alignment (Prism alternative cover test)	5 years
Binocular stereopsis at distance and near (Random dot stereopsis test)	5 years

Secondary Outcome Measures

Name	Time	Method
Newcastle control scores	5 years
The intermittent exotropia questionnaire	5 years

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China