Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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