Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00057

2 Trial Registration Date

2005-12-13

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

N/A

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible 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

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

i Name

Prof. Dennis SC Lam

ii Address

iii Phone

dennislam_cu_res@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Identification of genes for high myopia

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-03-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Eye Diseases

15 Intervention

i Types of intervention

Other

Please specify

Nil

ii Description/ name of Intervention/article

The purpose of this study project is to investigate the genes and their sequence alterations that are associated with high myopia.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 years including pateints follow-up, laboratory analysis, statistical analysis, data interpretation

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Control subjects with normal visual acuity, no ocular disorders, IOP velow 22 mm Hg and no family or personal history of high myopia.

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

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: Plan to carry out whole genome scan and linkage studies of 30 independent pedigrees of at least 3 generations, each with more than 10 members and 3 high myopia that we have recruited. None of these families have myopia associated disease such as Stickler's syndrome, Marfan syndrome and juvenile glaucoma.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Historical control

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

2004-08-10

21 Target Sample Size

300

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Advancing knowledge in basic molecular genetics.

24 Secondary Outcome

1. Affirm chromosomal loci linked to myopia. 2. Identify new myopia genes. 3. Reveal the frequencies of specific sequence alterations in the new putative myopia gene(s) in the local Chinese population. 4. Establish a basis to study interactive effects between environmental and genetic factors that contribute to myopia.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last 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