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Tertiary Care for Visual Developmental Disorders in Pre-school Children

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Visual Developmental Disorders

Treatments

Other: Tertiary care
Other: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT03251456
SYSU-OPH-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,114 patients

Sex

All

Ages

4 to 7 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,114 participants in 2 patient groups

Tertiary care
Experimental group
Treatment:
Other: Tertiary care
Usual care
Active Comparator group
Treatment:
Other: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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