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Ocular Function in Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010422
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Diagnostic Test: no intervention
no intervention

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
Diagnostic Test: no intervention
no intervention




Primary Outcome Measures :
  1. cornea innervation [ Time Frame: 30 min ]
    cornea innervation

  2. visual function [ Time Frame: 30 min ]
    blinking reflex



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010422


Contacts
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Contact: Yi Ling Chien 886-2-2312-3456 ext 66013 ylchien@hotmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yi Ling Chien, M.D., Ph.D.    886-2-2312-3456 ext 66013    ylchien@hotmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yi Ling Chien National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04010422    
Other Study ID Numbers: 201904121RINC
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders