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Early Vision Screening in High-risk Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02678468
Recruitment Status : Unknown
Verified August 2017 by Yao-Lin Liu, Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : August 16, 2017
Information provided by (Responsible Party):
Yao-Lin Liu, Far Eastern Memorial Hospital

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

Condition or disease
Amblyopia Child

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Early Vision Screening With Automated Photorefraction in Pre-term, Low-birth- Weight and Development-delay Children in Far-Eastern Memorial Hospital, Taiwan
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

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

Primary Outcome Measures :
  1. positive predictive value of vision screening [ Time Frame: one year ]
    positive predictive value

Secondary Outcome Measures :
  1. Odds ratio of having amblyopia risk factors [ Time Frame: one year ]
    Odds ratio

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children born and regular followed at pediatric clinic in Far Eastern Memorial Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02678468

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Contact: Yao-Lin Liu, M.D. 886-289667000 ext 1349

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Far Eastern Memorial Hospital Recruiting
New Taipei City, Other, Taiwan, 235
Contact: Yao-Lin Liu    918255820   
Sponsors and Collaborators
Far Eastern Memorial Hospital
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Principal Investigator: Yao-Lin Liu, M.D. Far Eastern Memorial Hospital
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Responsible Party: Yao-Lin Liu, M.D., Far Eastern Memorial Hospital Identifier: NCT02678468    
Other Study ID Numbers: 104077-F
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases