Ocular Function in Autism Spectrum Disorder

Recruiting

• Conditions: Autism; Ocular Surface Disease
• Interventions: Diagnostic Test: no intervention

• Registration Number: NCT04010422
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This study will investigate the visual function in individuals with ASD, with a particular focus on the ocular surface condition and visual function assessment.

Detailed Description

Anomalies in visual information processing can have a major effect on the life quality of individuals with autism spectrum disorders (ASD), including eye gaze abnormality, higher frequency of refractive errors (e.g., astigmatism, hypermetropia, and anisometropia), strabismus, abnormal blinking rate, disturbed eye movements that may be associated with or aggravated social communication deficits of ASD. However, little is known about the ocular surface conditions. This study will investigate the visual function in individuals with ASD, with a particular focus on the ocular surface condition. We plan to recruit 50 adults with ASD and 50 age-/sex-matched typically developing controls in this project, and perform visual function assessment.

Study Timeline

• Study Start: 2019-05-15
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Having a clinical diagnosis of autism spectrum disorder
2. Aged over 20 years; able to read and sign an informed consent form.
3. Clear conscious and can follow the instruction of opening eyes and movement toward all direction.

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Exclusion Criteria

1. Unable to cooperate with the examinations.
2. Younger than 20 years old.

TD group:

Inclusion Criteria:

1. Aged over 20 years; able to read and sign an informed consent form.
2. Clear conscious and can follow the instruction of opening eyes and movement toward all direction.

Exclusion Criteria:

1. Unable to cooperate with the examinations.
2. Younger than 20 years old.
3. Having a clinical diagnosis of autism spectrum disorder

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TD Group	no intervention	Inclusion Criteria: 1. Aged over 20 years; able to read and sign an informed consent form. 2. Clear conscious and can follow the instruction of opening eyes and movement toward all direction. Exclusion Criteria: 1. Unable to cooperate with the examinations. 2. Younger than 20 years old. 3. Having a clinical diagnosis of autism spectrum disorder
ASD group	no intervention	Inclusion Criteria: 1. Having a clinical diagnosis of autism spectrum disorder 2. Aged over 20 years; able to read and sign an informed consent form. 3. Clear conscious and can follow the instruction of opening eyes and movement toward all direction. Exclusion Criteria: 1. Unable to cooperate with the examinations. 2. Younger than 20 years old

Primary Outcome Measures

Name	Time	Method
cornea innervation	30 min	The participants will undergo HRT in vivo confocal microscopy. It is a laser scanning confocal microscope, operating by scanning a 670 nm laser beam in a raster pattern over the field of view. The system uses a high numerical aperture 63x objective lens (0.9 NA), and produces images with high contrast and better axial resolution (7.6 µm) than other in vivo confocal systems (9 µm for the TSCM and 24 µm for the Confoscan). The HRT-RCM provides new built-in software for 3D imaging of the corneal structure. Quantitative imaging of the subbasal nerve plexus could be per-formed by CCMetrics system, a custom software program developed at the University of Manchester.
Blinking reflex	30 min	Blinking rates manually calculated by two different research personnel and Tobii Pro X3-120 under two conditions: viewing preset film on the laptop and casual conversation with interviewer.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan