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CompletedNCT04152122Updated Nov 5, 2019

A Novel Dynamic Random-dot Stereopsis Assessment to Measure the Stereopsis in Intermittent Exotropia

An observational study in Dynamic Stereopsis in Intermittent Exotropia Patients, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 5 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-05.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
133
Ages
5 Years to 30 Years
Sex
All
01

Study summary

A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M), and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used. The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.

02

Conditions studied

  • Dynamic Stereopsis in Intermittent Exotropia Patients

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03

In context

Exotropia

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

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Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

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

04

Who can participate

Ages eligible
5 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A total of 83 cases X(T) patients and 50 normal subjects were enrolled in the study.

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

X(T) groups were as follows:

  1. near and distance exodeviation angles greater than 5 prism degrees (PD) and alternate cover tests and X(T) diagnosis by an experienced doctor;
  2. between 5 and 30 years old;
  3. 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
  4. absence of other ocular disorders or other systemic diseases.

Normal group were as follows:

  1. between 5 and 30 years old;
  2. 0.0 or better logMAR BCVA;
  3. near and distance exodeviation angles less than 5 PD and alternate cover tests; and
  4. no history of any ocular pathology or systemic disease.

Exclusion criteria

Exclusion Criteria:

X(T) groups were as follows:

  1. near and distance exodeviation angles less than 5 prism degrees (PD)
  2. younger than 5 or older than 30 years old;
  3. less than 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
  4. has other ocular disorders or other systemic diseases.

Normal group were as follows:

  1. younger than 5 or older than 30 years old;
  2. less than 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
  3. near and distance exodeviation angles more than 5 PD and alternate cover tests;
  4. has history of any ocular pathology or systemic disease.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
133 participants (actual)
Patient registry
No

Groups and cohorts

  • Intermittent exotropia group

    Intermittent exotropia group

    Diagnostic Test: The dynamic stereopsis test

  • Normal group

    Normal group

    Diagnostic Test: The dynamic stereopsis test

Interventions

  • Diagnostic testThe dynamic stereopsis test

    The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.

06

What researchers measure

Primary outcomes

  1. The mean reciprocal value of stereopsis

    The mean reciprocal value of stereopsis on the 1st day

    Time frame: 1st day

  2. The mean reciprocal value of stereopsis

    The mean reciprocal value of stereopsis on the 2nd month

    Time frame: 2nd month

  3. The mean reciprocal value of stereopsis

    The mean reciprocal value of stereopsis on the 6th month

    Time frame: 6th month

  4. The mean reciprocal value of stereopsis

    The mean reciprocal value of stereopsis on the 6th month

    Time frame: 12th month

07

Study locations

1 site
  • Zhongshan Opthalmic Center
    Guangzhou, Guangdong 510000, China
08

References and documents

Individual participant data

Plan to share: No — A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M), and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used. The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04152122
Responsible party
Jin Yuan (Clinical Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Nov 5, 2019
Start date
Feb 1, 2017
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Nov 5, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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