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

• Sponsor: Inje University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03641040
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27.3
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Exotropia; Strabismus	Diagnostic Test: Video-oculography; Diagnostic Test: Alternative prism cover test	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
• Actual Study Start Date: Dec 21, 2017
• Anticipated Primary Completion Date: Mar 31, 2019
• Anticipated Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
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; measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT

Outcome Measures

Primary Outcome Measures

1. The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover [2 weeks after approval]

   The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Visual acuity >= 1.0/1.0

• Intermittent exotropia

• Cooperative

Exclusion Criteria:

• Other eye disease

• Have hyperopia, myopia > 2 diopter

• Have horizontal strabismus > 50 prism diopter

• Not cooperative, no agree

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Busan Paik hospital	Busan		Korea, Republic of

Sponsors and Collaborators

• Inje University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sung-Hyuk Moon, professor, Inje University
• ClinicalTrials.gov Identifier: NCT03641040
• Other Study ID Numbers: IJ1357913579
• First Posted: Aug 21, 2018
• Last Update Posted: Aug 23, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sung-Hyuk Moon, professor, Inje University: Video-oculography; Intermittent exotropia; ocular deviation
• Additional relevant MeSH terms: Strabismus; Exotropia

Study Results

No Results Posted as of Aug 23, 2018