Ocular Function in Autism Spectrum Disorder

Evaluating the Ocular Function of Adults With Autism Spectrum Disorder: Interrelationship Between Blinking Reflex and Cornea Innervation.

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

Study Overview

• Status: Recruiting
• Conditions: Autism; Ocular Surface Disease
• Intervention / Treatment: Diagnostic test: no intervention

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yi Ling Chien; Phone Number: 66013 886-2-2312-3456; Email: ylchien@hotmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yi Ling Chien, M.D., Ph.D.; Phone Number: 66013 886-2-2312-3456; Email: ylchien@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This is an observation study. We will recruit 50 adults with autism spectrum disorder aging over 20 years old from the Psychiatry Department, National Taiwan University Hospital. We will also recruit 50 adults without autism spectrum disorder aging over 20 years old from the Ophthalmology Department, National Taiwan University Hospital.

Description

ASD group:

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cornea innervation	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.	30 min
Blinking reflex	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.	30 min

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yi Ling Chien, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 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: 201904121RINC

Drug and device information, study documents

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