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Ocular Function in Autism Spectrum Disorder

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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

Tracking Information
First Submitted Date July 4, 2019
First Posted Date July 8, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date May 15, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2019)
  • cornea innervation [ Time Frame: 30 min ]
    cornea innervation
  • visual function [ Time Frame: 30 min ]
    blinking reflex
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ocular Function in Autism Spectrum Disorder
Official Title Evaluating the Ocular Function of Adults With Autism Spectrum Disorder: Interrelationship Between Blinking Reflex and Cornea Innervation.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Autism
  • Ocular Surface Disease
Intervention Diagnostic Test: no intervention
no intervention
Study Groups/Cohorts
  • 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
    Intervention: Diagnostic Test: 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
    Intervention: Diagnostic Test: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 4, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Yi Ling Chien 886-2-2312-3456 ext 66013 ylchien@hotmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010422
Other Study ID Numbers 201904121RINC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yi Ling Chien National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date June 2019