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NCT Number: NCT03251456

Tertiary Care for Visual Developmental Disorders in Pre-school Children

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.

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Key information

Conditions

Visual Developmental Disorders Eye Diseases Myopia Refractive Errors

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yudu

Ganzhou, Jiangxi, 342300, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tertiary care

Other
  • Inform the parents that there are abnormalities after eye disease screening of their children, and the program of tertiary care for visual developmental disorders
  • The children will be receiving the appropriate therapy in tertiary care and follow-up according to the clinical guidelines
  • Six months after receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.

Usual Care

Other
  • Inform the parents that there are abnormalities after eye disease screening of their children
  • Inform the parents that they should take their children to the hospital for further consultation
  • Six months after the receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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