Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00257

2 Trial Registration Date

2009-12-23

i Registration Status

Prospective

3 Secondary IDs

KC/KE-09-0156/ER-2

4 Source(s) of Funding

Nil

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

CHAN Kar Mun Carmen

ii Address

HK Eye Hospital, 147K Argyle Street , Kln, HK

iii Phone

7388 1054

iv Email

kmcc2001@hotmail.com

v Affiliation

HKEH/ Dept of Ophthalmology and Visual Sciences, CUHK

vi Country

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

i Name

CHAN Kar Mun Carmen

ii Address

HK Eye Hospital, 147K Argyle Street , Kln, HK

iii Phone

7388 1054

iv Email

kmcc2001@hotmail.com

v Affiliation

HKEH/ Dept of Ophthalmology and Visual Sciences, CUHK

vi Country

9 Official Scientific Title of the Study

A pilot study to evaluate the relationship between intracranial pressure, ocular pulse amplitude and spontaneous venous pulsation

10 Public Title

A pilot study to evaluate the relationship between intracranial pressure, ocular pulse amplitude and spontaneous venous pulsation

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Relationship between ICP, OPA and SVP

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?

2009-11-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Conditions leading to increased intracranial pressure

15 Intervention

i Types of intervention

Other

Please specify

This is an observational study

ii Description/ name of Intervention/article

Not applicable

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Not applicable

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Not applicable

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

1. Aged 18 years or older
2. Patients undergoing Lumbar puncture, or have lumber drain/ external ventricular drain in-situ
3. Able to give informed consent

ii Exclusion Criteria

1. Inability to be examined at slit-lamp
2. Severe ocular media clouding
3. Glaucoma
4. Optic neuropathies which may affect the appearance of the optic disc
5. Previous refractive surgery or significant corneal pathology which affects DCT measurement
6. Narrow drainage angle
7. Known allergy to Mydrin-P, topical fluorescein and topical local anaesthesia
8. Previous ocular venous occlusive disease
9. Hyperviscosity syndrome

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

2010-01-11

21 Target Sample Size

50

22 Recruitment Status

Complete

23 Primary Outcome

The relationship between a, b & c:
a. Ocular pulse pressure and intraocular pressure by dynamic contour tonometry
b. Presence/ absence of spontaneous venous pulsation
c. Intracranial pressure by lumbar puncture/ lumbar drain/ external ventricular drain

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-05-05

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-09000772

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil available

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Trial History Detail on 2014-05-05