Ocular Function in Autism Spectrum Disorder

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04010422
• Other study ID #: 201904121RINC
• Status: Recruiting
• Start date: May 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Yi Ling Chien
• Phone: 886-2-2312-3456
• Email: ylchien[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Ocular Surface Disease

Intervention

Diagnostic Test:
• no intervention
no intervention

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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