Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00654

2 Trial Registration Date

2019-10-24

i Registration Status

Prospective

3 Secondary IDs

BDF 180054

4 Source(s) of Funding

Beat Drugs Fund

5 Primary Sponsor

Beat Drugs Fund

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Jasmine Tsoi

ii Address

Rm501-502, The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital

iii Phone

22528865

iv Email

jastsoi@cuhk.edu.hk

v Affiliation

CCRB, CUHK

vi Country

HK

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

i Name

Marc Chong

ii Address

Rm501-502, The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital

iii Phone

22528716

iv Email

marc@cuhk.edu.hk

v Affiliation

CCRB, CUHK

vi Country

HK

9 Official Scientific Title of the Study

Development of Objective Measure of Psychotropic Substances Abuse Using Automatic Retinal Image Analysis (ARIA)

10 Public Title

Development of Objective Measure of Psychotropic Substances Abuse Using Automatic Retinal Image Analysis (ARIA)

i Public Title in Chinese 研究名稱

利用全自動化視網膜圖像分析技術(ARIA)建立一套客觀的精神藥物濫用的檢測標準

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2019-09-23

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2019.440

14 Medical Condition Being Studied

Psychotropic Substances Abuse

15 Intervention

i Types of intervention

Other

Please specify

N/A

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Age ≥ 18

Drug abuse before the screening date (for cases)

No drug use experience (for controls)

Willing to sign the inform consent

Willing to comply with procedures required in the protocol

ii Exclusion Criteria

Age < 18

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

Subjects are distress with flashlight or have experience with photosensitive seizure

Unwillingness or inability to comply with procedures required in the protocol

iii Age Minimum

18

iv Age Maximum

999

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

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2019-11-01

21 Target Sample Size

100 cases and 200 controls

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Retinal images characteristics between case and controls

ii The metric or method of measurement used

Retinal images, demographic and health questionnaires, duration of drug abuse, types of psychotropic substances

iii The timepoint(s) of primary interest

Once

24 Secondary Outcome

i The Name of the outcome

N/A

ii The metric or method of measurement used

N/A

iii The timepoint(s) of primary interest

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-10-25

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2019-10-24