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| Name | Class |
|---|---|
| Tsinghua University | OTHER |
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To screen and identify sensitive biomarkers for high myopia via a robust, convenient, and cost-effective approach according to the association between high myopia and concentration of biomarkers in tear fluid, saliva and blood among adults and children.
Myopia has emerged as a serious public health issue, with the prevalence increasing rapidly worldwide, especially in East Asia. Increasingly early onset of myopia leads to high myopia with sight-threatening complications (e.g., secondary cataracts, glaucoma, and retinal detachment) that cannot be treated by optical means.
A key goal of myopia research over the past decades has been to identify those sensitive biomarkers. Accurate monitoring of myopic-specific biomarkers is desirable for achieving early diagnosis, progression assessment, and prognostic management.
However, measurement of levels of MMPs in human have been restricted to aqueous humors, which is invasive and the findings are difficult to be replicated in other studies. In order to achieve the goal of convenient high myopic detection, the use of a panel of biomarkers using a multiplex approach may indeed be rapid and highly reproducible with potentially higher sensitivity and specificity than single biomarkers, such as MMP 2 for the early detection of high myopia.
In this study we have used a newly developed immunoassay technology, and identified a panel of novel biomarkers for early detection of high myopia by non-invasively evaluating several biomarkers that are measurable in the saliva and tear fluid of adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emmetropic subjects | Spherical equivalent (Diopter, D) to be between -0.5 and +0.5 D |
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| Low and moderate myopic subjects | Spherical equivalent (Diopter, D) to be less than -0.5 but over -6.0D |
| |
| High myopic subjects | Spherical equivalent (Diopter, D) to be over or equal to -6.0D |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample | Diagnostic Test | Blood collection Circulating serum concentrations of melatonin and dopamine were determined from fasting blood samples. Participants were required to fast from 10 pm the previous evening. A 5 mL serum blood sample was collected from the antecubital vein between 8.30 am and 10 am. Tear collection Tear samples were collected using Schirmer's strip without anesthesia between 8:30-10:00am. Tears were extracted in 200 μl of 1 X Phosphate Buffered Saline with 0.1% Tween-20 (PBST). Saliva collection Saliva samples were collected via the "passive drool" method with subjects in a seated position. Subjects were asked to rinse their mouth with water 10 minutes prior to saliva collection and to refrain from using lip makeup during the sampling period. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of TNF-α in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups | TNF-α: Tumor necrosis factor is an adipokine and a cytokine. | June 30, 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of IL-1 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups | IL-1: Interleukin 1 | June 30, 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of IL-10 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups | IL-10: Interleukin 10, an anti-inflammatory cytokine | June 30, 2023 |
| Concentration of IL-6 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups |
Children Inclusion Criteria
Adults Inclusion Criteria
Exclusion Criteria:
(10)Do not receive cycloplegia or have contraindications; (11)Poor overall condition, unable to follow up for a long time; (12)The subject refuses to participate in the research; (13)Other cases in which the researcher judges that it is not suitable for participation in the study.
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There are two levels of research, namely children and adults. Each level is divided into three groups of 20 subjects each. So about 120 subjects are anticipated in total. Taken into account the proportion of exclusion, 150 subjects are invited to recruitment.
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| Name | Affiliation | Role |
|---|---|---|
| Shi-Ming Li | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100073 | China |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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IL-6: Interleukin 6, a pro-inflammatory cytokine |
| June 30, 2023 |
| Concentration of TIMP in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups | TIMP: Tissue inhibitor of metalloproteinases, a family of proteins that act as enzyme inhibitors | June 30, 2023 |
| Concentration of MMP2 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups | MMP2: Proteins of the matrix metalloproteinase (MMP) family are involved in the breakdown of extracellular matrix in normal physiological processes | June 30, 2023 |
| Concentration of EGF in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups | EGF:Epidermal growth factor (EGF) is a protein that stimulates cell growth. | June 30, 2023 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |