Important Note: Redirection of Services to ChiCTR
We would like to inform you that the Clinical Trial Registry page will discontinue the function of updating trial information directly on this platform. However, you will still be able to view the existing registration details. For any updates to trial information, you can use the China Clinical Trial Registry (ChiCTR) directly at https://www.chictr.org.cn. This change will be fully implemented by 2024-Aug-05. Thank you for your attention.
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
2018-07-05
ChiCTR1800016582
2018-06-01
|
|
|
|
---|---|---|---|
No documents yet. |