Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-02-22 @ 12:58 AM
Study NCT ID:
NCT02678468
Status:
UNKNOWN
Last Update Posted:
2017-08-16
First Post:
2016-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Vision Screening in High-risk Children
Sponsor:
Far Eastern Memorial Hospital
Organization:
Study Overview
Official Title:
Early Vision Screening With Automated Photorefraction in Pre-term, Low-birth- Weight and Development-delay Children in Far-Eastern Memorial Hospital, Taiwan
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: