Evaluation of Sleep Related Disturbances in Patients of Acute Uveitis and Inflammatory Cystoid Macular Edema- An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- To assess the qualitative and quantitative aspects of sleep disturbances among patients with acute uveitis and inflammatory cystoid macular edema with the Pittsburgh Sleep Quality Index questionnaire at the first visit/baseline and statistically analyze the two for any association.
研究概览
简要总结
· Primary objective:
1. To assess the quality and quantity of sleep disturbances among patients with acute uveitis and inflammatory cystoid macular edema with a standardised validated questionnaire.
· Secondary objective:
To find out correlation between qualitative/ quantitative parameters of sleep and qualitative / quantitative OCT findings of inflammatory cystoid macular edema.
Hypothesis:
Correlation of sleep disturbances in patients with acute uveitis and inflammatory CME can help in unravelling other non-pharmacological methods in tackling uveitis and the associated CME like normalising sleep patterns to help decrease the side effects and dosage of steroids and improve quality of life. It will help in enhancing the understanding of the pathology of uveitis and designing a patient centric approach to the treatment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with acute uveitis.
- •Patients diagnosed with active inflammatory cystoid macular edema.
排除标准
- •Patients diagnosed with chronic uveitis.
- •Patient with traumatic uveitis.
- •Patient with post operative uveitis.
- •Patient with diabetic macular edema, diabetic retinopathy.
- •Patients diagnosed with Retinal Vein Occlusions.
- •Patients diagnosed with Retinal Dystrophies.
- •Patients with sleep disorders and under treatment for the same prior to study.
- •Patients with psychiatric illness or on treatment for the same
- •Patients with hearing impairment and speech disorders.
结局指标
主要结局
To assess the qualitative and quantitative aspects of sleep disturbances among patients with acute uveitis and inflammatory cystoid macular edema with the Pittsburgh Sleep Quality Index questionnaire at the first visit/baseline and statistically analyze the two for any association.
时间窗: 1 year 6 months
次要结局
- To find out the correlation between qualitative & quantitative parameters of sleep using the Pittsburgh Sleep Quality Index questionnaire & qualitative & quantitative OCT findings of inflammatory cystoid macular edema.(1 year 6 months)
- To conduct a follow up study with Consensus Sleep Diary at next follow up visit. (3 days for acute uveitis & 1 month for inflammatory CME)(1 year 6 months)
研究者
Dr Nandita Manjunath
Aravind Eye Hospital