NCT04010422

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

4.6 years

First QC Date

July 4, 2019

Last Update Submit

April 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

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

Interventions

no interventionDIAGNOSTIC_TEST

no intervention

ASD groupTD Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to cooperate with the examinations.
  • Younger than 20 years old.
  • TD group:
  • 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.
  • Unable to cooperate with the examinations.
  • Younger than 20 years old.
  • Having a clinical diagnosis of autism spectrum disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • Wu CS, Tsai HJ, Chien YL, Gau SS. All-Cause Mortality and Specific Causes of Death in Autism: A Nationwide Analysis. Autism Adulthood. 2025 Feb 5;7(1):81-92. doi: 10.1089/aut.2023.0103. eCollection 2025 Feb.

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yi Ling Chien

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 8, 2019

Study Start

May 15, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations