Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00494

2 Trial Registration Date

2015-12-07

i Registration Status

Prospective

3 Secondary IDs

2015.362

4 Source(s) of Funding

NA

5 Primary Sponsor

The Chinese UNiversity of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ms. Maria Lai

ii Address

Room 501-2, JC School of Public Health and Primary Care,
The Chinese University of Hong Kong,
Prince of Wales Hospital,
Shatin, N.T.
Hong Kong

iii Phone

2252 8865

iv Email

marialai@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong, China SAR

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Benny Zee

ii Address

Room 501-2, JC School of Public Health and Primary Care,
The Chinese University of Hong Kong,
Prince of Wales Hospital,
Shatin, N.T.
Hong Kong

iii Phone

2252-8865

iv Email

bzee@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong, China SAR

9 Official Scientific Title of the Study

A Pilot Study to develop automatic retinal image analysis for screening of Children with Autism Spectrum Disorder in primary care setting

10 Public Title

A Pilot Study to develop automatic retinal image analysis for screening of Children with Autism Spectrum Disorder in primary care setting

i Public Title in Chinese 研究名稱

以自動視網膜圖像分析系統(ARIAS)的方法篩查兒童自閉症的初步研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong, China SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-09-17

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.362

14 Medical Condition Being Studied

Autism Spectrum Disorder

15 Intervention

i Types of intervention

Other

Please specify

NA

ii Description/ name of Intervention/article

NA

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

School-age children with diagnosis of ASD

School-age childrend without diagnosis of ASD

ii Exclusion Criteria

Poor retinal images quality that cannot be used in the analysis

Subjects with other eye diseases which are not suitable for retinal imaging, such as severe cataract, glaucoma, atretopsia, corneal plague

Written consents are not granted by subjects' parents or guardians

iii Age Minimum

6

iv Age Maximum

17

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

1.To evaluate if specific characteristics including the retinal nerve fiber layer (RNFL) estimated by stereo fundus images are significantly associated with autism spectrum disorder as compared to healthy individuals.; 2.To explore the use of fundus retinal images as a screening tool .

20 Anticipated trial start date

2015-12-18

21 Target Sample Size

400

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Association between ASD and retinal characteristics

ii The metric or method of measurement used

Retinal images

iii The timepoint(s) of primary interest

Once

24 Secondary Outcome

i The Name of the outcome

NA

ii The metric or method of measurement used

NA

iii The timepoint(s) of primary interest

NA

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-02-02

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-01-07