Early Vision Screening in High-risk Children

August 12, 2017 updated by: Yao-Lin Liu, Far Eastern Memorial Hospital

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

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Other
      • New Taipei City, Other, Taiwan, 235
        • Recruiting
        • Far Eastern Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children born and regular followed at pediatric clinic in Far Eastern Memorial Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive predictive value of vision screening
Time Frame: one year
positive predictive value
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds ratio of having amblyopia risk factors
Time Frame: one year
Odds ratio
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Investigators

  • Principal Investigator: Yao-Lin Liu, M.D., Far Eastern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 12, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104077-F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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