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Trial record 21 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Amblyopia"

Early Vision Screening in High-risk Children

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ClinicalTrials.gov Identifier: NCT02678468
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : August 16, 2017
Sponsor:
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.

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

Group/Cohort
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02678468


Contacts
Contact: Yao-Lin Liu, M.D. 886-289667000 ext 1349 liuyaolin.tw@gmail.com

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
New Taipei City, Other, Taiwan, 235
Contact: Yao-Lin Liu    918255820    liuyaolin.tw@gmail.com   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Yao-Lin Liu, M.D. Far Eastern Memorial Hospital

Publications:
Responsible Party: Yao-Lin Liu, M.D., Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02678468     History of Changes
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:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms