Early Vision Screening in High-risk Children

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02678468
• Other study ID #: 104077-F
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2016
• Last updated: August 12, 2017
• Start date: February 2016
• Est. completion date: March 2018

Study information

• Verified date: August 2017
• Source: Far Eastern Memorial Hospital
• Contact: Yao-Lin Liu, M.D.
• Phone: 886-289667000
• Email: liuyaolin.tw[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia
• Child

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City	Other

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive predictive value of vision screening	positive predictive value	one year
Secondary	Odds ratio of having amblyopia risk factors	Odds ratio	one year