Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients: a Prospective, Cross-sectional and Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Age
研究概览
简要总结
Numerous terms have been used to describe epiretinal membrane (ERM): macular pucker, epimacular membrane, surface-wrinkling retinopathy, cellophane maculopathy and preretinal macular fibrosis. It is, by definition, a fibrocellular tissue found on the inner surface of the retina. It is semi-translucent and proliferates on or above the surface of the internal limiting membrane. It causes blurring and metamorphopsia, while mild cases are often asymptomatic.
ERM presence can degrade the acuity and the quality of vision, thus affecting the quality of life. There is evidence that it also has an adverse impact to the treatment options for patients suffering from macular disorders. More specifically, regarding to diabetic retinopathy, ERM seems to have a bidirectional etiopathogenetic relationship with its course and complications.
The aim of this study is to know the prevalence of ERM in the Brussel's population, the risk factors predisposing to ERM formation and if diabetic patients have a significantly higher prevalence of ERM in comparison to general population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects examined in the general or diabetes screening consultations of the Ophthalmology Department of the CHU Brugmann Hospital
排除标准
- •Women pregnant or breast-feeding
- •Hypersensitivity to tropicamide
- •Any macular pathology other than diabetic maculopathy
- •Prior retinal photocoagulation
- •Prior intravitreal injection
- •Prior retinal surgery
结局指标
主要结局
Age
时间窗: First standard of care consultation, up to 3 months
Age
Previous cataract surgery
时间窗: First standard of care consultation, up to 3 months
Previous cataract surgery
Educational level
时间窗: First standard of care consultation, up to 3 months
Educational level
Gender
时间窗: First standard of care consultation, up to 3 months
Gender
Diabetic Retinopathy classification
时间窗: First standard of care consultation, up to 3 months
Diabetic Retinopathy classification, if diagnosed (according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) classification)
Smoking status
时间窗: First standard of care consultation, up to 3 months
Smoking status
Population sub-type
时间窗: First standard of care consultation, up to 3 months
Population sub-type: Caucasian, African, Asian, Indian, American or Other
Diabetes type (for group A)
时间窗: First standard of care consultation, up to 3 months
Diabetes type (for group A)
Duration of medical treatment of diabetes
时间窗: First standard of care consultation, up to 3 months
Duration of medical treatment of diabetes (measured in months)
HbA1C (Glycated Haemoglobin) rate
时间窗: First standard of care consultation, up to 3 months
HbA1C rate (according to recent blood test)
Diagnose of ERM
时间窗: First standard of care consultation, up to 3 months
Diagnose of ERM
次要结局
未报告次要终点
研究者
Laurence Postelmans
Head of clinic
Brugmann University Hospital