Systematic Imaging Examination in ODD | NCT03957642

Studies
Systematic Imaging Examination in ODD

NCT03957642

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

May 23, 2019Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Optic Disk Drusen

Interventions

Not provided

Countries

China

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

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2019Actual

Primary Completion Date

Jan 1, 2020Estimated

Completion Date

Jan 1, 2020Estimated

First Submitted Date

May 19, 2019

First Submission Date that Met QC Criteria

May 19, 2019

First Posted Date

May 21, 2019Actual

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

May 21, 2019

Last Update Posted Date

May 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiang Zhu, Professor, Third Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

Third Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To evaluate the diagnostic value of systematic ophthalmologic imaging examination in the diagnosis of embedded optic disc drusen (ODD) in adolescents with mild visual impairment.

Detailed Description

Patients are evaluated through optometric examination, fundus photography, visual field examination, OCT, US, and FFA.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection rate of embedded ODD	detection rate of embedded ODD	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female.
Age 14-28.
The results of visual acuity examination suggest mild visual impairment.
The results of ophthalmologic examination showed that the blurred degree of the local boundary of the optic disc was different and the optic disc was congested.

Exclusion Criteria:

patients with amblyopia.
patients with neurological disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

28 Years

Standard Ages

ChildAdult

Study Population

Adolescents with mild visual impairment accompanied by disc flushing, crowded optic disc, and a blurred disc halo.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiang Zhu, Doctor	Contact	13826452564		0628zhuxiang@163.com

Overall Officials

Name	Affiliation	Role
Xiuhua Jia, Dorctor	Third Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The third affiliated hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510630	China

Condition Browse Module

MeSH Terms

ID	Term
D015594	Optic Disk Drusen

Ancestor Terms

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided