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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Visual Function

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Mingmei Liu; Phone Number: +862227313336; Email: liu_mingmei@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Eye Hospital
      • Contact: Ya Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The plan is to enroll nearly 1,000 children with autism in the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
refractive error	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	6 months
strabismus	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	6 months
amblyopia	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OCTA	Fundus blood perfusion and retinal thickness were observed	6months
eye tractor	The correlation between eye movement and visual function was assessed	6months

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Estimated): November 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: YK2023002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No