Early Vision Screening in High-risk Children
- Conditions
- ChildAmblyopia
- Registration Number
- NCT02678468
- Lead Sponsor
- Far Eastern Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- Children with known ophthalmic diseases
- Children with congenital systemic diseases
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method positive predictive value of vision screening one year positive predictive value
- Secondary Outcome Measures
Name Time Method Odds ratio of having amblyopia risk factors one year Odds ratio
Trial Locations
- Locations (1)
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Other, Taiwan