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Status unknownNCT03641040Updated Aug 23, 2018

The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia

An interventional study of Video-oculography and Alternative prism cover test in Intermittent Exotropia and Strabismus, sponsored by Inje University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-23.

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

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
5 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intermittent Exotropia
  • Strabismus

Keywords

  • Video-oculography
  • Intermittent exotropia
  • ocular deviation
03

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Visual acuity >= 1.0/1.0
  • Intermittent exotropia
  • Cooperative

Exclusion criteria

Exclusion Criteria:

  • Other eye disease
  • Have hyperopia, myopia > 2 diopter
  • Have horizontal strabismus > 50 prism diopter
  • Not cooperative, no agree
04

Study design

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

Study arms

  • Experimental
    VOG group

    Measurement: Video-oculography(VOG) measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.

    Diagnostic Test: Video-oculography

  • Active comparator
    APCT group

    Measurement: Alternative prism cover test(APCT) measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT

    Diagnostic Test: Alternative prism cover test

Interventions

  • Diagnostic testVideo-oculography

    measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.

  • Diagnostic testAlternative prism cover test

    measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 weeks after approval

06

Study locations

1 site
  • Busan Paik hospital
    Busan, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03641040
Lead sponsor
Inje University
Responsible party
Sung-Hyuk Moon (professor, Inje University) — Principal investigator
First posted
Aug 21, 2018
Start date
Dec 21, 2017
Primary completion
Mar 31, 2019 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
Aug 23, 2018

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 status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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