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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03422016




Registration number
NCT03422016
Ethics application status
Date submitted
30/01/2018
Date registered
5/02/2018
Date last updated
11/01/2022

Titles & IDs
Public title
Electroretinogram in Autistic Spectrum Disorders
Scientific title
The Incidence of Altered Light Responses in Children With Autistic Spectrum Disorders
Secondary ID [1] 0 0
17PP33
Universal Trial Number (UTN)
Trial acronym
ERG in ASD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - electroretinogram (ERG)

autistic spectrum disorder - intelligence quotient IQ\>85 age 4-25yrs

control - age 4-25yrs no eye disorder


Diagnosis / Prognosis: electroretinogram (ERG)
an ERG is a measure of the eyes response to a flash of light
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
light adapted electroretinogram
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* cohort 1: individuals with diagnosis ASD with an IQ measure exceeding 85
* cohort 2: typically developed controls without diagnosis of ASD
Minimum age
4 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* a history of eye disease or treatment or seizure medicines that may alter retinal function

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/04/2020
Sample size
Target
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders University - Adelaide
Recruitment hospital [2] 0 0
Swinburne University of Technology - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Yale University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Swinburne University of Technology
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study aims to find out the incidence of a reduced light adapted electroretinogram (ERG) b-wave amplitude in children with a diagnosis of Autism Spectrum Disorders (ASD).
Trial website
https://clinicaltrials.gov/study/NCT03422016
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dorothy A Thompson, PhD
Address 0 0
Consultant Clinical Scientist Visual Electrophysiology, Great Ormond Street Hospital for Children London UK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03422016