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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
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intermittent Exotropia focused on measuring Video-oculography, Intermittent exotropia, ocular deviation

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 19, 2018
Last Updated
August 21, 2018
Sponsor
Inje University
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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

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