Early Vision Screening in High-risk Children

NCT ID: NCT02678468

Last Updated: 2017-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Amblyopia Child

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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high-risk group

children with birth history of pre-term, low birth weight children with develop delay

No interventions assigned to this group

normal group

children with normal birth history and normal development

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yao-Lin Liu

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yao-Lin Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Locations

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Far Eastern Memorial Hospital

New Taipei City, Other, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yao-Lin Liu, M.D.

Role: CONTACT

886-289667000 ext. 1349

Facility Contacts

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Yao-Lin Liu

Role: primary

918255820

References

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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.

Reference Type BACKGROUND
PMID: 23791414 (View on PubMed)

Other Identifiers

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104077-F

Identifier Type: -

Identifier Source: org_study_id

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