Ocular Function in Autism Spectrum Disorder

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04010422
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 19.6
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism; Ocular Surface Disease	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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Evaluating the Ocular Function of Adults With Autism Spectrum Disorder: Interrelationship Between Blinking Reflex and Cornea Innervation.
• Actual Study Start Date: May 15, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. cornea innervation [30 min]

   cornea innervation

2. visual function [30 min]

   blinking reflex

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT04010422
• Other Study ID Numbers: 201904121RINC
• First Posted: Jul 8, 2019
• Last Update Posted: Jul 8, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Autistic Disorder; Autism Spectrum Disorder

Study Results

No Results Posted as of Jul 8, 2019