NCT03422016

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 Health

90
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
3 countries

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2020

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

January 30, 2018

Last Update Submit

January 10, 2022

Conditions

Autism Spectrum Disorder

Keywords

electroretinogram

Outcome Measures

Primary Outcomes (1)

  • light adapted electroretinogram

    incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder

    12 months

Study Arms (2)

autistic spectrum disorder

intelligence quotient IQ\>85 age 4-25yrs

Diagnostic Test: electroretinogram (ERG)

control

age 4-25yrs no eye disorder

Diagnostic Test: electroretinogram (ERG)

Interventions

electroretinogram (ERG)DIAGNOSTIC_TEST

an ERG is a measure of the eyes response to a flash of light

autistic spectrum disordercontrol

Eligibility Criteria

Age4 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

individuals diagnosed with ASD and typically developing controls

You may qualify if:

  • cohort 1: individuals with diagnosis ASD with an IQ measure exceeding 85
  • cohort 2: typically developed controls without diagnosis of ASD

You may not qualify if:

  • a history of eye disease or treatment or seizure medicines that may alter retinal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Yale University

New Haven, Connecticut, 06520, United States

Location

Flinders University

Adelaide, South Australia, Australia

Location

Swinburne University of Technology

Melbourne, Australia

Location

Great Ormond Street Hospital for Children NHS Trust

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Electroretinography

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Dorothy A Thompson, PhD

    Consultant Clinical Scientist Visual Electrophysiology, Great Ormond Street Hospital for Children London UK

    PRINCIPAL INVESTIGATOR

  • Paul Constable, PhD

    Head Of Teaching Optometry, Flinders Vision Autism Centre, Flinders University, Australia

    STUDY DIRECTOR

  • James McPartland, PhD

    Associate Professor of Child Psychiatry and Psychology, Director, Yale Developmental Disabilities Clinic, Yale University, USA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 5, 2018

Study Start

September 3, 2018

Primary Completion

March 3, 2020

Study Completion

April 3, 2020

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)AU(2)US(1)