Follow up study of the patients enrolled in a hospital based multi center registry for common medical retinal diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 3
- 主要终点
- 1.To evaluate the progression of the disease after the visit
研究概览
简要总结
Our aim was to develop a multicentre registry in order to facilitate future RCTs in common medical retinal diseases amenable to treatment with biologics like anti VEGF. Such a registry will facilitate recruitment by matching potential participants interested in research with approved clinical studies using study entry criteria taken from patient visiting OPDs after obtaining their informed consent. The follow up study will evaluate the progression of the disease and change of visual acuity of the patients who were already enrolled in the registry entitled “A hospital-based multicentre registry for common medical retinal diseasesâ€
This is a hospital based multicenter registry which will be conducted without any intervention. The data of patients who were already in the registry entitled “A hospital-based multicentre registry for common medical retinal diseases†will be collected.
Data collection includes details of any new comorbid diseases , previous diagnosis as per baseline visit, current diagnosis as per latest visit, any procedure done after baseline visit, ophthalmic assessment including best corrected visual acuity (logmar) , intraocular pressure, OCT-central macular thickness , OCT-central macular volume and mydriatic fundus photographs.
The assessment of changes in continuous variable outcomes like BCVA, CMT, and CMV from baseline to follow-up involves the utilization of either Repeated Measures ANOVA or the Friedman Test.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with these aforementioned stages of diabetic retinopathy,
- •Central and branch retinal vein occlusions
- •Age related macular degeneration or CNVM who are already enrolled in the registry entitled “A hospital-based multicentre registry for common medical retinal diseasesâ€
- •Patients who were already enrolled in the registry entitled “A hospital-based multicentre registry for common medical retinal diseases.
排除标准
- •Patients who were not enrolled in the registry entitled “A hospital-based multicentre registry for common medical retinal diseases.
结局指标
主要结局
1.To evaluate the progression of the disease after the visit
时间窗: 6 Months
次要结局
- 1. To evaluate the real world treatment of patients who were enrolled into the registry.(2. To evaluate the efficacy of treatment of patients through change in vision.)
研究者
Dr Gopal S Pillai
Amrita Institute of Medical Sciences and Research Centre, Kochi Kerala