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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06122519
Other study ID # YK2023002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date April 1, 2024

Study information

Verified date November 2023
Source Tianjin Eye Hospital
Contact Mingmei Liu
Phone +862227313336
Email liu_mingmei@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility 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 Design


Locations

Country Name City State
China Tianjin Eye Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 OCTA Fundus blood perfusion and retinal thickness were observed 6months
Secondary eye tractor The correlation between eye movement and visual function was assessed 6months
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