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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02736526
Acronym
SOMIX
Enrollment
280
Registered
2016-04-13
Start date
2015-11-30
Completion date
2022-12-31
Last updated
2021-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Intermittent Exotropia

Keywords

moderate intermittent exotropia, surgical treatment, observation

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.

Interventions

PROCEDURErecession or resection of the horizontal extraocular muscles

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Ocular alignment (Prism alternative cover test)5 years
Binocular stereopsis at distance and near (Random dot stereopsis test)5 years

Secondary

MeasureTime frame
Newcastle control scores5 years
The intermittent exotropia questionnaire5 years

Countries

China

Contacts

Primary ContactTao Shen, M.D.
shentao@mail2.sysu.edu.cn86-13824449536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026