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Clinical Trials/NCT06122519
NCT06122519
Recruiting
N/A

Disorders and the Effect of Corresponding Treatment on the Quality of Life of Children and Adolescents With Autism and Their Caregivers

Tianjin Eye Hospital1 site in 1 country1,000 target enrollmentApril 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Tianjin Eye Hospital
Enrollment
1000
Locations
1
Primary Endpoint
amblyopia
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study mainly investigated the incidence of eye diseases in children with autism spectrum disorder(ASD) in Tianjin area, and analyzed related risk factors, so as to raise attention to eye diseases in children with ASD. To evaluate the impact of ophthalmic treatment on the quality of life of children with autism and their primary caregivers.

Detailed Description

In recent years, the incidence of autism has increased year by year, which has brought a heavy burden to society and families. For the special group of children with autism spectrum disorder, previous studies focused on the lack of comprehensive and accurate visual function characteristics and defects of this group. In the early stage, it was believed that there was a certain correlation between visual impairment and autism, and some patients with visual impairment were misdiagnosed as autism. Moreover, some studies have shown that the incidence of refractive errors and oblique amblyopia in autistic children is significantly higher than that in normal children. This study mainly includes two parts: On the one hand, investigate the autism children in Tianjin area to understand the incidence of eye diseases. On the other hand, children with eye problems were given relevant interventions, such as optometry, amblyopia training, strabismus surgery, etc., to assess the impact of the corresponding treatment on the quality of life of the children and their primary caregivers.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
April 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with ASD but without medical intervention. To cooperate with relevant inspectors.

Exclusion Criteria

  • Brain organic diseases (such as tumors, strokes, epilepsy, etc.) and serious physical diseases (such as heart, liver, kidney and other organ dysfunction, cancer, etc.);Do not cooperate to check.

Outcomes

Primary Outcomes

amblyopia

Time Frame: 6 months

Patients with amblyopia were treated with amblyopia, followed up for at least half a year, and the influence of the quality of life of children and adolescents and the main caregivers after optometry was observed

refractive error

Time Frame: 6 months

Patients with ametropia were given endoscopic treatment, followed up for at least half a year, and the influence of endoscopic treatment on the quality of life of children, adolescents and primary caregivers was observed

strabismus

Time Frame: 6 months

Patients with strabismus requiring surgical correction were given surgical treatment, followed up for at least half a year, and the effects on the quality of life of children, adolescents and primary caregivers were observed

Secondary Outcomes

  • OCTA(6months)
  • eye tractor(6months)

Study Sites (1)

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