CompletedNCT03119311Updated Jul 21, 2017

A Novel Diagnostic Method for Exotropia Using Video-oculography

An interventional study of Video-oculography and APCT in Strabismus and Exotropia, sponsored by Inje University. Completed at 1 site in Korea, Republic of. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by Inje University · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 34
Allocation: Non-randomized
Ages: 4 Years and older
Sex: All

Study 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.

Conditions studied

Strabismus
Exotropia

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Who can participate

Ages eligible: 4 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 34 participants (actual)

Study arms

Experimental
VOG group
Video-oculography
Diagnostic Test: Video-oculography
Active comparator
APCT group
alternative prism cover test
Diagnostic Test: APCT

Interventions

Diagnostic testVideo-oculography
Diagnostic Method for Exotropia Using Video-oculography
Diagnostic testAPCT
alternative prism cover test

What researchers measure

Primary outcomes

The angle of ocular deviation (degree,°) measured by VOG and PCT
strabismic angle (degree,°) measured by VOG and PCT
Time frame: 2 weeks after approval

Study locations

1 site

Busan Paik hospital
Busan, Korea, Republic of

References and documents

Publications

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. PubMed 29566654 ↗

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT03119311
Lead sponsor: Inje University
Responsible party: Sung-Hyuk Moon (professor, Inje University) — Principal investigator
First posted: Apr 18, 2017
Start date: Apr 25, 2017
Primary completion: Jun 30, 2017
Completion: Jul 10, 2017
Last update: Jul 21, 2017

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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