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

Dynamic Stereopsis in Intermittent Exotropia Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152122
• Other study ID #: 2016MEKY032
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: November 2019
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dynamic Stereopsis in Intermittent Exotropia Patients
• Exotropia

Intervention

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.

Locations

Country	Name	City	State
China	Zhongshan Opthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean reciprocal value of stereopsis	The mean reciprocal value of stereopsis on the 1st day	1st day
Primary	The mean reciprocal value of stereopsis	The mean reciprocal value of stereopsis on the 2nd month	2nd month
Primary	The mean reciprocal value of stereopsis	The mean reciprocal value of stereopsis on the 6th month	6th month
Primary	The mean reciprocal value of stereopsis	The mean reciprocal value of stereopsis on the 6th month	12th month