A Novel Diagnostic Method for Exotropia Using Video-oculography

NCT ID: NCT03119311

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-25

Study Completion Date

2017-07-10

Brief Summary

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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.

Detailed Description

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Conditions

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Strabismus Exotropia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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VOG group

Video-oculography

Group Type EXPERIMENTAL

Video-oculography

Intervention Type DIAGNOSTIC_TEST

Diagnostic Method for Exotropia Using Video-oculography

APCT group

alternative prism cover test

Group Type ACTIVE_COMPARATOR

APCT

Intervention Type DIAGNOSTIC_TEST

alternative prism cover test

Interventions

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Video-oculography

Diagnostic Method for Exotropia Using Video-oculography

Intervention Type DIAGNOSTIC_TEST

APCT

alternative prism cover test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* have vertical strabimus\> 5prism diopter, not cooperative, no agree
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Sung-Hyuk Moon

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Busan Paik hospital

Busan, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 29566654 (View on PubMed)

Other Identifiers

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IJ1234567

Identifier Type: -

Identifier Source: org_study_id

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