Screening and Identification of Biomarkers for High Myopia by a Rapid Method
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Concentration of TNF-α in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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.
结局指标
主要结局
Concentration of TNF-α in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
时间窗: June 30, 2023
TNF-α: Tumor necrosis factor is an adipokine and a cytokine.
次要结局
- Concentration of IL-1 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups(June 30, 2023)