NCT03641040

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 21, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

August 19, 2018

Last Update Submit

August 21, 2018

Conditions

Intermittent ExotropiaStrabismus

Keywords

Video-oculographyIntermittent exotropiaocular deviation

Outcome Measures

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

    2 weeks after approval

Study Arms (2)

VOG group

EXPERIMENTAL

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

APCT group

ACTIVE COMPARATOR

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

Video-oculographyDIAGNOSTIC_TEST

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

VOG group
Alternative prism cover testDIAGNOSTIC_TEST

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

APCT group

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Busan Paik hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Strabismus

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

August 19, 2018

First Posted

August 21, 2018

Study Start

December 21, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2020

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

KR(1)