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The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia

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ClinicalTrials.gov Identifier: NCT03641040
Recruitment Status : Enrolling by invitation
First Posted : August 21, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sung-Hyuk Moon, Inje University

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.

Condition or disease Intervention/treatment Phase
Intermittent Exotropia Strabismus Diagnostic Test: Video-oculography Diagnostic Test: Alternative prism cover test Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2020


Arm Intervention/treatment
Experimental: VOG group
Measurement: Video-oculography(VOG) measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
Diagnostic Test: Video-oculography
measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.

Active Comparator: APCT group
Measurement: Alternative prism cover test(APCT) measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT
Diagnostic Test: Alternative prism cover test
measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT




Primary Outcome Measures :
  1. The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover [ Time Frame: 2 weeks after approval ]
    The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03641040


Locations
Korea, Republic of
Busan Paik hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Inje University

Responsible Party: Sung-Hyuk Moon, professor, Inje University
ClinicalTrials.gov Identifier: NCT03641040     History of Changes
Other Study ID Numbers: IJ1357913579
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sung-Hyuk Moon, Inje University:
Video-oculography
Intermittent exotropia
ocular deviation

Additional relevant MeSH terms:
Strabismus
Exotropia
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases