Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00129

2 Trial Registration Date

2007-05-19

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

Carmen Chan

ii Address

Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, HK

iii Phone

7388 1054

iv Email

kmcc2001@hotmail.com

v Affiliation

Hong Kong Eye Hospital/ CUHK

vi Country

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

i Name

Carmen Chan

ii Address

Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, HK

iii Phone

7388 1054

iv Email

kmcc2001@hotmail.com

v Affiliation

Hong Kong Eye Hospital/ CUHK

vi Country

9 Official Scientific Title of the Study

Quantitative assessment of optic disc morphology of non-glaucomatous optic neuropathy

10 Public Title

Quantitative assessment of optic disc morphology of non-glaucomatous optic neuropathy

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

OCT/CSLO for non-glaucomatous ON

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?

2007-05-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Non-glaucomatous optic neuropathies

15 Intervention

i Types of intervention

Other

Please specify

Nil

ii Description/ name of Intervention/article

This is an observational study

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

NA

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

NA

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: 1. Patients with unilateral or bilateral non-glaucomatous optic neuropathies. 2. Intraocular pressure (IOP) <21 mmHg; 3. Informed consent; 4. Aged 18 years or older

ii Exclusion Criteria

Exclusion criteria 1. Other posterior segment ocular pathology (e.g., diabetic retinopathy [except background diabetic retinopathy], age-related macular degeneration, glaucoma) 2. Significant media opacity preventing adequate image capture by OCT/ CSLO 3. Refractive error >5 diopters (D) equivalent sphere or >3 D of astigmatism.

iii Age Minimum

18

iv Age Maximum

Nil set

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

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

2007-05-21

21 Target Sample Size

100

22 Recruitment Status

Recruiting

23 Primary Outcome

optic disc parameters as measured by optical coherence tomography and confocal scanning laser ophthalmoscope at baseline (all) and at year 5 (subgroup)

24 Secondary Outcome

Correlation with visual field at baseline (all) and at year 5 (subgroup)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TNRC-09000694

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 2011-03-01