AutismNCT04010422
Ocular Function in Autism Spectrum Disorder
An observational study of Autism and Ocular Surface Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism, Ocular Surface Disease
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- Unable to cooperate with the examinations.
- Younger than 20 years old.
- TD group:
- Unable to cooperate with the examinations.
- Younger than 20 years old.
- Having a clinical diagnosis of autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yi Ling Chien, M.D., Ph.D., 886-2-2312-3456 ext. 66013, ylchien@hotmail.com
About this study
Official title: Evaluating the Ocular Function of Adults With Autism Spectrum Disorder: Interrelationship Between Blinking Reflex and Cornea Innervation.
This study will investigate the visual function in individuals with ASD, with a particular focus on the ocular surface condition and visual function assessment.
Read the 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.
- Conditions
- Autism, Ocular Surface Disease
- Being tested
- no intervention
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionDiagnostic test
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start15 May 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Ling Chien, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010422
- Sponsor's protocol ID
- 201904121RINC
- Status last verified
- Apr 2023
- First submitted
- 4 Jul 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40151655
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Ocular Function of Adults With Autism Spectrum Disorder: Interrelationship Between Blinking Reflex and Cornea Innervation.
- ClinicalTrials.gov ID
- NCT04010422
- Acronym / sponsor ID
- 201904121RINC
- Conditions
- Autism, Ocular Surface Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Diagnostic Test: no interventionInclusion 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 | – | Diagnostic Test: no interventionInclusion 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (6 listed)
- Unable to cooperate with the examinations.
- Younger than 20 years old.
- Unable to cooperate with the examinations.
- Younger than 20 years old.
- Having a clinical diagnosis of autism spectrum disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Diagnostic test | ASD group, TD Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 40151655Wu 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.
Related trials for Autism
Recruiting
Word Learning From Parentese in Autistic Children
Autism, Autism Spectrum Disorder
Recruiting
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Autism, Autism Spectrum Disorder
Recruiting
Impact of an E-Learning Coaching for Parents of Young Children With Autism
Autism Spectrum Disorder
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Ling Chien principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Ocular Surface Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ling Chien (886-2-2312-3456 ext. 66013, ylchien@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cornea innervation (time frame: 30 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.