Early Vision Screening in High-risk Children

Early Vision Screening With Automated Photorefraction in Pre-term, Low-birth- Weight and Development-delay Children in Far-Eastern Memorial Hospital, Taiwan

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02678468

Enrollment

200

Registered

2016-02-09

Start date

2016-02-29

Completion date

2018-03-31

Last updated

2017-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia, Child

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Years to 2 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Taiwan

Contacts

Primary ContactYao-Lin Liu, M.D.

liuyaolin.tw@gmail.com886-289667000

Outcome results