Characteristics of Eye Diseases in Children and Adolescents With Autism Spectrum Disorders and the Effect of Corresponding Treatment on the Quality of Life of Children and Adolescents With Autism and Their Caregivers

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06122519
Collaborator
(none)
1,000
1
12
83.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Disorders and the Effect of Corresponding Treatment on the Quality of Life of Children and Adolescents With Autism and Their Caregivers
    Actual Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. refractive error [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

    2. strabismus [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

    3. amblyopia [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

    Secondary Outcome Measures

    1. OCTA [6months]

      Fundus blood perfusion and retinal thickness were observed

    2. eye tractor [6months]

      The correlation between eye movement and visual function was assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Eye Hospital Tianjin Tianjin China

    Sponsors and Collaborators

    • Tianjin Eye Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT06122519
    Other Study ID Numbers:
    • YK2023002
    First Posted:
    Nov 8, 2023
    Last Update Posted:
    Nov 8, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 8, 2023