Tertiary Care for Visual Developmental Disorders in Pre-school Children

June 18, 2019 updated by: Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1114

Phase

  • Not Applicable

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

  • China
    • Jiangxi
      • Ganzhou, Jiangxi, China, 342300
        • Yudu

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

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who are aged 4-7 years and of Chinese citizen
  2. Who is willing to sign the consent form
  3. 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:

  1. Unwilling to sign the consent form
  2. Exiting eye diseases and already receiving therapies and follow up

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Other: Usual Care
  1. Inform the parents that there are abnormalities after eye disease screening of their children
  2. Inform the parents that they should take their children to the hospital for further consultation
  3. Six months after the receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.
Experimental: Tertiary care
Other: Tertiary care
  1. Inform the parents that there are abnormalities after eye disease screening of their children, and the program of tertiary care for visual developmental disorders
  2. The children will be receiving the appropriate therapy in tertiary care and follow-up according to the clinical guidelines
  3. Six months after receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cost-effective of the tertiary care for visual developmental disorders
Time Frame: 6 months
The cost of the disease management model will be determined by the cost per child when receiving the therapy including the travelling and medical fee, and the time they spent. And the clinical efficacy of the tertiary care for visual developmental disorders will be determined by whether or not the child receiving the appropriate therapy according to the clinical guideline.
6 months

Collaborators and Investigators

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

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Yizhi LIU, MD,PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Study Director: Yangfa ZENG, MD,Master, Zhongshan Ophthalmic Center, Sun Yat-sen University

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 (Actual)

August 18, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-OPH-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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