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

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.

Study Overview

• Status: Completed
• Conditions: Dynamic Stereopsis in Intermittent Exotropia Patients
• Intervention / Treatment: Diagnostic test: The dynamic stereopsis test

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zhongshan Opthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intermittent exotropia group	Diagnostic test: The 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.
Normal group	Diagnostic test: The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean reciprocal value of stereopsis	The mean reciprocal value of stereopsis on the 1st day	1st day
The mean reciprocal value of stereopsis	The mean reciprocal value of stereopsis on the 2nd month	2nd month
The mean reciprocal value of stereopsis	The mean reciprocal value of stereopsis on the 6th month	6th month
The mean reciprocal value of stereopsis	The mean reciprocal value of stereopsis on the 6th month	12th month

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (ACTUAL): November 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• Other Study ID Numbers: 2016MEKY032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No