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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04152122
Recruitment Status : Completed
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment
Dynamic Stereopsis in Intermittent Exotropia Patients Diagnostic Test: The dynamic stereopsis test

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Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Dynamic Random-dot Stereopsis Assessment to Measure the Stereopsis in Intermittent Exotropia
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Group/Cohort Intervention/treatment
Intermittent exotropia group
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
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.




Primary Outcome Measures :
  1. The mean reciprocal value of stereopsis [ Time Frame: 1st day ]
    The mean reciprocal value of stereopsis on the 1st day

  2. The mean reciprocal value of stereopsis [ Time Frame: 2nd month ]
    The mean reciprocal value of stereopsis on the 2nd month

  3. The mean reciprocal value of stereopsis [ Time Frame: 6th month ]
    The mean reciprocal value of stereopsis on the 6th month

  4. The mean reciprocal value of stereopsis [ Time Frame: 12th month ]
    The mean reciprocal value of stereopsis on the 6th month



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152122


Locations
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China, Guangdong
Zhongshan Opthalmic Center
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
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Responsible Party: Jin Yuan, Clinical Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04152122    
Other Study ID Numbers: 2016MEKY032
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases