Back to resultsA Novel Diagnostic Method for Exotropia Using Video-oculography
Primary Purpose
Strabismus, Exotropia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Video-oculography
APCT
Sponsored by
About this trial
This is an interventional diagnostic trial for Strabismus
Eligibility Criteria
Inclusion Criteria:
- have horizontal strabismus, cooperative, visual acuity >= 1.0/1.0
Exclusion Criteria:
- have vertical strabimus> 5prism 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
Video-oculography
alternative prism cover test
Outcomes
Primary Outcome Measures
The angle of ocular deviation (degree,°) measured by VOG and PCT
strabismic angle (degree,°) measured by VOG and PCT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03119311
Brief Title
A Novel Diagnostic Method for Exotropia Using Video-oculography
Official Title
A Novel Diagnostic Method for Exotropia Using Video-oculography
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
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
Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists measured the angle of ocular deviation using alternate prism cover test (APCT). The video files and data with the changes in ocular deviation during the alternate cover test were obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared the value obtained using VOG and the angle of a rotating model eye, and subsequently made a new linear equation using these data. The calculated values obtained using VOG were compared with those obtained using APCT to determine the diagnostic accuracy of VOG.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus, Exotropia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VOG group
Arm Type
Experimental
Arm Description
Video-oculography
Arm Title
APCT group
Arm Type
Active Comparator
Arm Description
alternative prism cover test
Intervention Type
Diagnostic Test
Intervention Name(s)
Video-oculography
Intervention Description
Diagnostic Method for Exotropia Using Video-oculography
Intervention Type
Diagnostic Test
Intervention Name(s)
APCT
Intervention Description
alternative prism cover test
Primary Outcome Measure Information:
Title
The angle of ocular deviation (degree,°) measured by VOG and PCT
Description
strabismic angle (degree,°) measured by VOG and PCT
Time Frame
2 weeks after approval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
have horizontal strabismus, cooperative, visual acuity >= 1.0/1.0
Exclusion Criteria:
have vertical strabimus> 5prism 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
Citations:
PubMed Identifier
29566654
Citation
Park N, Park B, Oh M, Moon S, Kim M. A quantitative analysis method for comitant exotropia using video-oculography with alternate cover. BMC Ophthalmol. 2018 Mar 22;18(1):80. doi: 10.1186/s12886-018-0747-9.
Results Reference
derived
Learn more about this trial
A Novel Diagnostic Method for Exotropia Using Video-oculography
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