Early Vision Screening in High-risk Children | NCT02678468

Studies
Early Vision Screening in High-risk Children

NCT02678468

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Aug 16, 2017Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Amblyopia
Child

Interventions

Not provided

Countries

Taiwan

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

Aug 2017

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

Feb 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Feb 5, 2016

First Submission Date that Met QC Criteria

Feb 5, 2016

First Posted Date

Feb 9, 2016Estimated

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

Aug 12, 2017

Last Update Posted Date

Aug 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 effect of early vision screening with automated photorefraction device in high risk children

Detailed Description

Pre-term, low-birth-weight, and development delay are well-known risk factors related to higher incidence of high refractive error and strabismus, which can potentially lead to amblyopia and is regarded as amblyopia risk factors. This project is a cross-sectional controlled study. Our study includes high-risk group and normal group. High-risk group includes children with birth history of pre-term, low-birth-weight and the diagnosis of development delay in FEMH. Normal group enrolled age-matched children without those risk factors. Vision screening by FDA-approved photorefraction device as well as comprehensive ophthalmic exams for definite diagnosis will be performed on the high-risk group and the normal group.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high-risk group		children with birth history of pre-term, low birth weight children with develop delay
normal group		children with normal birth history and normal development

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
positive predictive value of vision screening	positive predictive value	one year

Secondary Outcomes

Measure	Description	Time Frame
Odds ratio of having amblyopia risk factors	Odds ratio	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High risk group: children with gestational age less than 36weeks, birth weight less than 2500g and children diagnosed as develop delay
Normal group: children with normal birth history and normal development

Exclusion Criteria:

Children with known ophthalmic diseases
Children with congenital systemic diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

2 Years

Standard Ages

Child

Study Population

Children born and regular followed at pediatric clinic in Far Eastern Memorial Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yao-Lin Liu, M.D.	Contact	886-289667000	1349	liuyaolin.tw@gmail.com

Overall Officials

Name	Affiliation	Role
Yao-Lin Liu, M.D.	Far Eastern Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital	Recruiting	New Taipei City	Other	235	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23791414	Background	Bloomberg JD, Suh DW. The accuracy of the plusoptiX A08 photoscreener in detecting risk factors for amblyopia in central Iowa. J AAPOS. 2013 Jun;17(3):301-4. doi: 10.1016/j.jaapos.2013.03.014.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014786	Vision Disorders