The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
Primary Purpose
Intermittent Exotropia, Strabismus
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Video-oculography
Alternative prism cover test
Sponsored by
About this trial
This is an interventional diagnostic trial for Intermittent Exotropia focused on measuring Video-oculography, Intermittent exotropia, ocular deviation
Eligibility Criteria
Inclusion Criteria:
- Visual acuity >= 1.0/1.0
- Intermittent exotropia
- Cooperative
Exclusion Criteria:
- Other eye disease
- Have hyperopia, myopia > 2 diopter
- Have horizontal strabismus > 50 prism diopter
- Not cooperative, no agree
Sites / Locations
- Busan Paik hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VOG group
APCT group
Arm Description
Measurement: Video-oculography(VOG) measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
Measurement: Alternative prism cover test(APCT) measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT
Outcomes
Primary Outcome Measures
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03641040
Brief Title
The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
Official Title
The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fifteen subjects with intermittent exotropia were included. The subjects were asked to fixate on a black-on-white optotype at 1 m, which subtended a visual angle of 50 min of arc, equating to a Snellen optotype of 20/200. The video files and data about ocular deviations were obtained using VOG with alternate cover test. Investigators analyzed angles of ocular deviations in dominant and non-dominant eyes, compared with values of VOG and deviation angles of the alternative prism cover test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Exotropia, Strabismus
Keywords
Video-oculography, Intermittent exotropia, ocular deviation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VOG group
Arm Type
Experimental
Arm Description
Measurement: Video-oculography(VOG) measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
Arm Title
APCT group
Arm Type
Active Comparator
Arm Description
Measurement: Alternative prism cover test(APCT) measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT
Intervention Type
Diagnostic Test
Intervention Name(s)
Video-oculography
Intervention Description
measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
Intervention Type
Diagnostic Test
Intervention Name(s)
Alternative prism cover test
Intervention Description
measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT
Primary Outcome Measure Information:
Title
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
Description
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
Time Frame
2 weeks after approval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Visual acuity >= 1.0/1.0
Intermittent exotropia
Cooperative
Exclusion Criteria:
Other eye disease
Have hyperopia, myopia > 2 diopter
Have horizontal strabismus > 50 prism diopter
Not cooperative, no agree
Facility Information:
Facility Name
Busan Paik hospital
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
We'll reach out to this number within 24 hrs