UnknownNot Applicable

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

China280 participantsStarted 2015-11

Plain-language 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.

Who can participate

Age range5 Years – 18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Simultaneous perception and fusion point in synoptophore, but no normal function of fusion and stereopsis.
✓. Age at from 5 to 18 years, sex unlimited.
✓. No treatment for IXT previously (including surgical and non-surgical treatment).
✓. No amblyopia.
✓. Signed informed consent form voluntarily.

Exclusion criteria

✕. Accompanied with ocular organic diseases.
✕. Accompanied with systemic diseases (e.g. nervous system disease).
✕. Unable to regular follow-up (e.g. from countryside and outlying district).
✕. Investigators concluded that should be excluded.

What they're measuring

Ocular alignment (Prism alternative cover test)

Timeframe: 5 years

Binocular stereopsis at distance and near (Random dot stereopsis test)

Timeframe: 5 years

Trial details

NCT IDNCT02736526

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06

Contact for this trial

Tao Shen, M.D.

86-13824449536 shentao@mail2.sysu.edu.cn

View on ClinicalTrials.gov More Moderate Intermittent Exotropia trials