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Trial History Detail on 2018-06-01

CUHK_CCRB00611

2018-06-01

Prospective

NA

NA

NA

NA

Not Applicable

Miss Wong Sin Ting Janice

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

39435825

janicewong@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Prof. Leung Kai Shun Christopher

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

39435825

cksleung@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Identification of biomarkers for glaucoma in the tear film by next generation proteomic technology

Identification of biomarkers for glaucoma in the tear film by next generation proteomic technology

利用下一代蛋白質組學技術鑑定淚膜中青光眼的生物標誌物

Hong Kong

Yes

2018-05-04

Joint CUHK-NTEC Clinical Research Ethics Committee

CRE Ref. No. 2018.065

glaucoma

Procedure

Newly diagnosed glaucoma group subjects will be recruited. Participants receive the following ocular examinations to check for eligibility for inclusion. The examinations take around 3 hours.
1. Refraction
2. Visual acuity
3. Slit lamp biomicroscopy
4. Fundus examination
5. IOP measurement
6. Central Corneal Thickness
7. Retinal Nerve Fiber L ayer RNFL measurement by Optical coherence tomography (OCT)
8. Visual field (for the newly diagnosed glaucoma participants only)

When participants fulfill the inclusion criteria, a registered optometrist will collect tears sample from participants' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes. No local anaesthetics or other eye drops will be applied. Following tear collection, each sample will be placed in a clean tube and stored at -80oC for further analysis. In order to secure the identity of the subjects, a number code will be assigned for specimen identification.

Using glass capillary tubes to collect tears

Ten to fifteen microliters tear

30 minutes

once

Control group subjects will be recruited. Participants receive the following ocular examinations to check for eligibility for inclusion. The examinations take around 3 hours.
1. Refraction
2. Visual acuity
3. Slit lamp biomicroscopy
4. Fundus examination
5. IOP measurement
6. Central Corneal Thickness
7. Retinal Nerve Fiber L ayer RNFL measurement by Optical coherence tomography (OCT)
8. Visual field (for the newly diagnosed glaucoma participants only)

When participants fulfill the inclusion criteria, a registered optometrist will collect tears sample from participants' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes. No local anaesthetics or other eye drops will be applied. Following tear collection, each sample will be placed in a clean tube and stored at -80oC for further analysis. In order to secure the identity of the subjects, a number code will be assigned for specimen identification.

Using glass capillary tubes to collect tears

Ten to fifteen microliters tear

30 minutes

once

Control group subject inclusion criteria: 1. Chinese adults aged between 40-60

2. Spectacle corrected monocular VA: 0.2 logMAR or better after full correction

3. No contact lens wear

4. Free of ocular and systemic abnormalities e.g. cataract, diabetes mellitus (DM) Intraocular pressure (IOP): 21 mmHg or less in both eyes

5. Difference in IOP between two eyes: 3 mmHg or less

6. Able to give written consent

Newly diagnosed glaucoma group subject inclusion criteria: 1. Early onset of signs of primary open-angled glaucoma (POAG)

2. Intraocular pressure (IOP): 22 mmHg or more in one or both eyes

3. Sign of optic nerve abnormalities according to the classification of Mild or Early Stage Glaucoma in the Glaucoma ICD-10 quick reference guide of the American Academy of Ophthalmology (AAO)

4. Free from other ocular and systemic diseases e.g. cataract, DM etc.

5. Able to give written consent

1. Regular contact lens wear

2. DM, severe heart disease, history of stroke

3. Dry eye disease

4. Underwent LASIK surgery

40

60

Both Male and Female

Observational

Non-randomized

Not Applicable

Open label

Parallel

Other

N/A

2018-06-29

14 subjects with newly diagnosed glaucoma will be recruited at CUHK Eye Centre

Not Yet Recruiting

Differentially protein expressions

Using ProteinPilot 5.0 software

21 months

Not applicable

No

2018-07-05

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