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Clinical Trials/NCT03251456
NCT03251456
Completed
Not Applicable

Tertiary Care Based Visual Developmental Diseases Management Model Among Preschool Children in China: a Cluster Randomized Controlled Trial

Zhongshan Ophthalmic Center, Sun Yat-sen University1 site in 1 country1,114 target enrollmentAugust 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Visual Developmental Disorders
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Enrollment
1114
Locations
1
Primary Endpoint
The consultation rate in six month after the parents receiving the visual screening report
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Visual development disorders are major public health problems among children especially in China. How to find an effective and economic way to manage the larger number of children in China remains exploring. The national basic public health services of China offer visual acuity screening for preschool children for free every year. The aim of this study is to demonstrate the feasibility, cost-effective and the influence factors of compliance of tertiary care for visual developmental disorders in pre-school children after screening, and whether this disease management model is more effective and superior than the current medical care in china.

Detailed Description

Visual development disorders including amblyopia , strabismus ,refractive error are an important public health problem among children, and the visual impairment caused by visual development disorders is lifelong and can be profound. Timely discovering and treatment of visual development disorders are significant for the recovering of visual function in children. The national basic public health services of China offer the basic visual acuity screening every year for free. In this study, the investigators try to explore the cost-effective and compliance of the national basic public health services based tertiary care model for the management of visual development disorders among preschool children. This Tertiary care based on disease management model among preschool children was conducted at Yudu county, Jiangxi province, in China. Preschool vision screening relied on the national basic public health services of China (refractive errors examined by the Retinomax autorefractor). Children who failed the screening were randomized into two groups, the intervention group: their parents will be informed and transferred to an ophthalmologist and optometrist at Ophthalmic Referral Center, receiving basic eye examination and therapy (visual corrected by glasses and periodic review); The control group: their parents will be informed and suggest them to take their children to the hospital for further examination by themselves.

Registry
clinicaltrials.gov
Start Date
August 18, 2017
End Date
June 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yizhi Liu

Clinical Professor,director of Zhongshan Ophthalmic Center

Zhongshan Ophthalmic Center, Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Patients who are aged 4-7 years and of Chinese citizen
  • Who is willing to sign the consent form
  • Children at the kindergarten will receiving the eye diseases screening of public health equalization programs in China, and there are abnormal findings after screening

Exclusion Criteria

  • Unwilling to sign the consent form
  • Exiting eye diseases and already receiving therapies and follow up

Outcomes

Primary Outcomes

The consultation rate in six month after the parents receiving the visual screening report

Time Frame: 6 months

The consultation rate will be determined by the number of children who had visual screening abnormal actually go to hospital for consultation by telephone follow-up.

Secondary Outcomes

  • The cost-effective of the tertiary care for visual developmental disorders(6 months)

Study Sites (1)

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