Screening and Identification of Biomarkers for High Myopia by a Rapid Method
- Conditions
- High Myopia
- Interventions
- Diagnostic Test: blood sample
- Registration Number
- NCT05803174
- Lead Sponsor
- Beijing Tongren Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
- Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for adults and children over 6 years old;
- Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
- Secondary myopia, genetic disease or connective tissue- related myopia;
- Moderate or severe ptosis;
- Congenital cataract, glaucoma;
- Other fundus diseases other than myopic related fundus lesions;
- Intraocular or refractive surgery history;
- The refractive medium is turbid, and it is impossible to take a clear fundus image; (9)Unable to cooperate with fundus image shooting and other examination;
(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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Emmetropic subjects blood sample Spherical equivalent (Diopter, D) to be between -0.5 and +0.5 D Low and moderate myopic subjects blood sample Spherical equivalent (Diopter, D) to be less than -0.5 but over -6.0D High myopic subjects blood sample Spherical equivalent (Diopter, D) to be over or equal to -6.0D
- Primary Outcome Measures
Name Time Method Concentration of TNF-α in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups June 30, 2023 TNF-α: Tumor necrosis factor is an adipokine and a cytokine.
- Secondary Outcome Measures
Name Time Method Concentration of IL-1 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups June 30, 2023 IL-1: Interleukin 1
Trial Locations
- Locations (1)
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China