NCT03119311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

April 4, 2017

Last Update Submit

July 18, 2017

Conditions

StrabismusExotropia

Outcome Measures

Primary Outcomes (1)

  • The angle of ocular deviation (degree,°) measured by VOG and PCT

    strabismic angle (degree,°) measured by VOG and PCT

    2 weeks after approval

Study Arms (2)

VOG group

EXPERIMENTAL

Video-oculography

Diagnostic Test: Video-oculography

APCT group

ACTIVE COMPARATOR

alternative prism cover test

Diagnostic Test: APCT

Interventions

Video-oculographyDIAGNOSTIC_TEST

Diagnostic Method for Exotropia Using Video-oculography

VOG group
APCTDIAGNOSTIC_TEST

alternative prism cover test

APCT group

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Busan Paik hospital

Busan, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29566654DERIVED

MeSH Terms

Conditions

StrabismusExotropia

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 18, 2017

Study Start

April 25, 2017

Primary Completion

June 30, 2017

Study Completion

July 10, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

KR(1)