A Novel Diagnostic Method for Exotropia Using Video-oculo... | NCT03119311

Studies
A Novel Diagnostic Method for Exotropia Using Video-oculography

NCT03119311

Sponsor

Inje University

Status

Completed

Last Update Posted

Jul 21, 2017Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Strabismus
Exotropia

Interventions

Video-oculography
APCT

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2017Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jul 10, 2017Actual

First Submitted Date

Apr 4, 2017

First Submission Date that Met QC Criteria

Apr 17, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2017

Last Update Posted Date

Jul 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VOG group	Experimental	Video-oculography	Diagnostic Test: Video-oculography
APCT group	Active Comparator	alternative prism cover test	Diagnostic Test: APCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video-oculography	Diagnostic Test	Diagnostic Method for Exotropia Using Video-oculography	VOG group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The angle of ocular deviation (degree,°) measured by VOG and PCT	strabismic angle (degree,°) measured by VOG and PCT	2 weeks after approval

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

have vertical strabimus> 5prism diopter, not cooperative, no agree

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Busan Paik hospital		Busan			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29566654	Derived	Park N, Park B, Oh M, Moon S, Kim M. A quantitative analysis method for comitant exotropia using video-oculography with alternate cover. BMC Ophthalmol. 2018 Mar 22;18(1):80. doi: 10.1186/s12886-018-0747-9.

ID	Term
D015835	Ocular Motility Disorders
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

ID	Term
D013285	Strabismus
D005099	Exotropia