Risk of Posterior Staphyloma in Highly Myopic Europeans : From Epidemiology to Anatomy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Differential gene expression between myopic patients with and without staphyloma
研究概览
简要总结
In this cross-sectionnal study the aim is to increase the understanding of posterior staphyloma through a unique European consortium. Therefore, all eligible patients that either visit the outpatient clinic at Radboud in Nimegen, the Netherlands, or visit University Hopital Puerta de HierroMajadahonda in Madrid, Spain, or visit University Hospital Cochin in Paris, France, and after consenting, will be included.
600 high myopic European cases are expecting. A standardized protocol in all centers in order to create a uniform dataset.
Besides the standard of care, blood samples will be collected.
All data collected will be stored in an onlie Castor database
详细描述
Main objective: To characterize the phenotype, genetics and biology of myopic staphyloma in a European population (three countries involved).
Primary Outcome Measure:
The primary objective of this study is to identify genetic variants (SNPs) significantly associated with the presence of posterior staphyloma in individuals of European ancestry with high myopia.
A genome-wide association study (GWAS) will be conducted in 600 highly myopic Caucasian participants, divided into two well-phenotyped groups:
- 300 patients with posterior staphyloma (case group)
- 300 patients without posterior staphyloma (control group) SNP allele frequencies will be compared between the two groups using logistic regression models adjusted for relevant covariates (age, sex, axial length, and genetic ancestry via principal components).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with high myopia (axial length ≥ 26.00 mm or degree of myopia of at least -6 diopters), with and without posterior staphyloma
- •Adults aged 18 years or over
- •Patient with high myopia (axial length ≥ 26.00 mm or degree of myopia of at least -6 diopters), with good quality retinal imaging
- •Patient who has signed a consent form to participate in the study
- •Patient who is a beneficiary of a social security scheme or who is entitled to it
排除标准
- •Any systemic or ocular pathologies with an impact on the posterior segment of the eye
- •Patient with a systemic pathology likely to affect the posterior segment of the eye:
- •Systemic inflammatory disease: sarcoidosis, rheumatoid arthritis, systemic lupus erythematosus, Horton's disease
- •Patients with retinitis pigmentosa
- •Patients with syndromic myopia
- •Patients with myopia associated with a genetic disease such as hereditary vitreoretinopathy
- •Patients under guardianship, curatorship or legal protection, as well as pregnant or breastfeeding women (article L1121-5 of the CSP).
研究组 & 干预措施
AM A : High Myopia without myopic staphyloma
干预措施: blood sampling for DNA (Biological)
ARM B : High myopia with myopic staphyloma
干预措施: blood sampling for DNA (Biological)
结局指标
主要结局
Differential gene expression between myopic patients with and without staphyloma
时间窗: Through study completion, an average of 1 year.
Genetic analysis
次要结局
- Establish correlations between the phenotype and systemic molecular markers(Through study completion, an average of 1 year.)
- Compare phenotype of staphyloma between France and 2 other European countries: Netherlands and Spain(25 months)