A Novel Diagnostic Method for Exotropia Using Video-oculography

• Sponsor: Inje University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03119311
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 13.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Strabismus; Exotropia	Diagnostic Test: Video-oculography; Diagnostic Test: APCT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: A Novel Diagnostic Method for Exotropia Using Video-oculography
• Actual Study Start Date: Apr 25, 2017
• Actual Primary Completion Date: Jun 30, 2017
• Actual Study Completion Date: Jul 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VOG group Video-oculography	Diagnostic Test: Video-oculography; Diagnostic Method for Exotropia Using Video-oculography
Active Comparator: APCT group alternative prism cover test	Diagnostic Test: APCT; alternative prism cover test

Outcome Measures

Primary Outcome Measures

1. The angle of ocular deviation (degree,°) measured by VOG and PCT [2 weeks after approval]

   strabismic angle (degree,°) measured by VOG and PCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• have vertical strabimus> 5prism 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: NCT03119311
• Other Study ID Numbers: IJ1234567
• First Posted: Apr 18, 2017
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

• 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
• Additional relevant MeSH terms: Strabismus; Exotropia

Study Results

No Results Posted as of Jul 21, 2017