High Focused Evaluation of Atherosclerotic Risk Profile in Retinal Thrombosis: Vascular Events Incidence, Sex Involvement and Interventional Outcomes Assessed by Ophthalmologists and Internists Network
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Retinal Venous Occlusion Prevalence
研究概览
简要总结
The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic retinopathy, and is a common cause of unilateral visual loss. The risk factors that predispose to RVO are many and are generally the same as those found in vascular alterations involving other parts of the body, as in the case of stroke or coronary heart disease. Several authors have attempted to determine whether the pathogenesis of RVO can be of arterial type, considering the disease as consequent to atherosclerosis, rather than resulting from venous disease. Although less frequent than the other diseases RVO affects considerably on health care costs. Direct medical costs showed that in one year a patient with this disease has a higher than average cost for a patient with hypertension or glaucoma. Knowing the prevalence of the disease in Italy and identify modifiable risk factors, recognizing additional risk factors related to gender, genetic predisposition and especially the social-economic and cultural background in the pathogenesis of RVO, are the objectives that led to the planning of this study. In order to assess the prevalence of the disease and the current "clinical practice" we aim to create an online register between Italian specialist centers (ophthalmic emergency care and thrombosis centers) with immediate portability and usability of the data.
详细描述
The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic retinopathy, and is a common cause of unilateral visual loss. The occlusion of a branch of the central retinal vein (BRVO) and central retinal vein occlusion (CRVO) are two topics discussed and very deserving of further study, especially for the need of greater clarity arising from the availability of new diagnostic and especially therapeutic opportunities.
The literature on the prevalence of RVO is not particularly rich, and the results of the available studies are very heterogeneous because such studies are conducted on a few cases, using different methodologies and are mainly characterized by a different distribution of risk factors among the different populations. In this regard, it was particularly interesting a publication of 2010 which proposed a combined analysis of the main study population (population based study).
The sample of the final analysis was of 49 869 subjects, and the results showed that the retinal vein occlusion overall prevalence, standardized for age and sex, is 5.2 per 1000, of which 4.42 and 0.80 to BRVO and CRVO respectively. Despite the slightly higher prevalence in females, this difference wasn't statistically significant.
In contrast, the prevalence of venous occlusion increases with increasing age in a statistically significant manner, both in the overall analysis of the occlusions of branch and central, that for the individual entities. This pattern is characteristic of chronic degenerative diseases and in fact the RVO has a behavior very similar to that of these diseases, probably because the risk factors (especially those such as atherosclerosis and systemic hypertension) increases with age.
The results provided by these systematic analysis are particularly important because they provide a reliable estimate of RVO prevalence in general population; must be considered, however, the inherent limitations mainly concerning potential sources of heterogeneity, such as different methodologies used, the fact that most of the studies were carried out on a single ethnic group, often with different distribution of risk factors and therefore were not suitable to capture these differences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Clinical Suspicion of Retinal Vein Occlusion
- •Written Informed Consent
排除标准
- •Pregnancy
- •Short Life Expectancy
结局指标
主要结局
Retinal Venous Occlusion Prevalence
时间窗: Baseline
The primary outcome result is about the description of RVO prevalence among the study population.
次要结局
- Atherosclerotic Risk Profile in RVO(Baseline)
- Visual Acuity(2 Years)
- Major Adverse Cardiovascular Events(2 Years)
- RVO Recurrence(2 Years)
研究者
Stefania Basili
Associate Professor
University of Roma La Sapienza
