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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this record recently (last verified Aug 2018), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2017, registered Aug 2018).
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

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Keywords

  • Video-oculography
  • Intermittent exotropia
  • ocular deviation
03

In context

Strabismus

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 82 interventional studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Inje University is the lead sponsor of 93 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 site
  • Busan Paik hospital
    Busan, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Mar 2019, 15 months after the start.

Of 35 non-industry interventional studies with no phase under Strabismus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's planned 15 months is below that.

Counting every sponsor, half of 35 studies reached it within 17 months; a quarter within 8 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2018
First posted
Aug 21, 2018
StartActual
Dec 21, 2017
Primary completionEst.
Mar 31, 2019
CompletionEst.
Mar 31, 2020
Last update
Aug 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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Discussion

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