NCT05803174

Screening and Identification of Biomarkers for High Myopia by a Rapid Method

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• High Myopia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood sample	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.

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-05-31
• Completion: 2023-07-31
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: China