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A Novel Diagnostic Method for Exotropia Using Video-oculography

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. Identifier: NCT03119311
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):
Sung-Hyuk Moon, Inje University

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.

Condition or disease Intervention/treatment Phase
Strabismus Exotropia Diagnostic Test: Video-oculography Diagnostic Test: APCT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: A Novel Diagnostic Method for Exotropia Using Video-oculography
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : July 10, 2017

Arm Intervention/treatment
Experimental: VOG group
Diagnostic Test: Video-oculography
Diagnostic Method for Exotropia Using Video-oculography

Active Comparator: APCT group
alternative prism cover test
Diagnostic Test: APCT
alternative prism cover test

Primary Outcome Measures :
  1. The angle of ocular deviation (degree,°) measured by VOG and PCT [ Time Frame: 2 weeks after approval ]
    strabismic angle (degree,°) measured by VOG and PCT

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • have horizontal strabismus, cooperative, visual acuity >= 1.0/1.0

Exclusion Criteria:

  • have vertical strabimus> 5prism diopter, not cooperative, no agree

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 identifier (NCT number): NCT03119311

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Korea, Republic of
Busan Paik hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Inje University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sung-Hyuk Moon, professor, Inje University Identifier: NCT03119311    
Other Study ID Numbers: IJ1234567
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases