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Clinical Trials/NCT04010422
NCT04010422
Recruiting
Not Applicable

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

National Taiwan University Hospital1 site in 1 country100 target enrollmentMay 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
National Taiwan University Hospital
Enrollment
100
Locations
1
Primary Endpoint
cornea innervation
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2019
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.
  • 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

Outcomes

Primary Outcomes

cornea innervation

Time Frame: 30 min

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.

Blinking reflex

Time Frame: 30 min

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.

Study Sites (1)

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