Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00055

2 Trial Registration Date

2005-12-14

i Registration Status

Retrospective

3 Secondary IDs

not applicable

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

Ms Joyce KUNG

ii Address

UEC, 3/F Hong Kong Eye Hospital, 147K Argyle St., Kln

iii Phone

2762 3134

iv Email

joycekung@cuhk.eduh.hk

v Affiliation

Department of Ophthalmology and Visual Sciences

vi Country

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

i Name

Prof. Dennis SC Lam

ii Address

UEC, 3/F Hong Kong Eye Hospital, 147K Argyle St., Kln

iii Phone

2762 3134

iv Email

email dennislam_cu_res@cuhk.edu.hk

v Affiliation

Department of Ophthalmology and Visual Sciences

vi Country

9 Official Scientific Title of the Study

Identification of genes for high myopia using parent-offspring trios

10 Public Title

Identification of genes for high myopia using parent-offspring trios

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

not applicable

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?

2004-05-13

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

N/A

ii Description/ name of Intervention/article

Carry out whole genome scan and linkage studies of 200 parent-offspring trios, generations, each with more than 10 members and 3 high myopia that we have recruited. None of these families have myopia associated diseases such as Stickler's syndrome, Marfan syndrome and juvenile glaucoma.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

N/A

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

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: At least one of the family members has myopia members at ≤-6.0D, or high myopia developed at an early age.

ii Exclusion Criteria

Peole with ophthalmic diseases other than refractive errors

iii Age Minimum

Nil

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Observational

19 Study 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

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-07-01

21 Target Sample Size

600

22 Recruitment Status

Unknown

23 Primary Outcome

To verify the chromosomal loci linked to myopia.

24 Secondary Outcome

To 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

ChiCTR-ONRC-05000676

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-09-11