ClinicalTrials.gg
Status unknownNCT02736526SOMIXUpdated Dec 22, 2021

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

An interventional study of recession or resection of the horizontal extraocular muscles in Moderate Intermittent Exotropia, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-12-22.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2015, registered Apr 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Moderate Intermittent Exotropia

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Keywords

  • moderate intermittent exotropia
  • surgical treatment
  • observation
03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's planned enrollment of 280 is above the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form voluntarily.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    Surgical treatment

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

    Procedure: recession or resection of the horizontal extraocular muscles

  • No intervention
    Observation only

Interventions

  • Procedurerecession or resection of the horizontal extraocular muscles
06

What researchers measure

Primary outcomes

  1. Ocular alignment (Prism alternative cover test)

    Time frame: 5 years

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

    Time frame: 5 years

Secondary outcomes

  1. Newcastle control scores

    Time frame: 5 years

  2. The intermittent exotropia questionnaire

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02736526
Responsible party
Tao Shen (M. D., Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Apr 13, 2016
Start date
Nov 2015
Primary completion
Jun 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Dec 22, 2021

Study contacts

Tao Shen, M.D.
Contact
shentao@mail2.sysu.edu.cn
86-13824449536
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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