Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00056

2 Trial Registration Date

2005-12-13

iRegistration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

N/A

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Prof. Dennis SC Lam

ii Address

iii Phone

dennislam_cu_res@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

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

i Name

Prof. Dennis SC Lam

ii Address

iii Phone

email

iv Email

dennislam_cu_res@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Genetic analysis for eye disease

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-06-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Eye Diseases

15Intervention

i Types of intervention

Other

Please specify

Nil

ii Description/ name of Intervention/article

To affirm chromosomal loci linked to eye diseases like high myopia, identify new genes related to eye diseases, reveal the frequencies of specific sequence alterations in the new putative gene(s) in the local Chinese population.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 years

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

Recruit normal subjects for studying the molecular information on genetic eye diseases involving Chinese patients.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Control subjects inclusion criteria: 1. Age 50 and above. 2. Normal visual acuity. 3. IOP below 22 mm Hg.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-07-01

21 Target Sample Size

500

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Advancing knowledge in basic molecular genetics and possible utilization of molecular information for clinical application.

24 Secondary Outcome

1. Affirm chromosomal loci linked to eye disease. 2. Identify new genes related to eye disease. 3. Reveal the frequencies of specific sequence alterations in the new putative gene(s) in the local Chinese popultaion.

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2015-06-23

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-12-13