search
Back to results

A 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
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Strabismus

Eligibility Criteria

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

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

First Posted
April 4, 2017
Last Updated
July 18, 2017
Sponsor
Inje University
search

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

We'll reach out to this number within 24 hrs