Pateint-reported Outcomes and Objective Eye Dryness Evaluation in Primary Sjögren's Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Variability in the intensity of patient-reported symptoms
研究概览
简要总结
The objective of this observational study is to develop new tools to assess primary Sjögren's syndrome (pSS) symptoms and to measure the severity of eye involvement in these patients.
详细描述
All clinical trials evaluating the efficacy of immunomodulatory drugs in pSS are negative. This could be due to a lack of sensitivity of the outcome measures used so far to define the response. In this study, investigator will evaluate the feasability, tolerability, and performance of new tools to assess disease evolution:
- investigator will develop a webapp to measure the intensity of the symptoms at home on a daily basis (ecological assessment)
- investigator will evaluate new ophthalmologic procedures, already used in other conditions but never in pSS, which assess the severity of eye involvement in the disease
- investigator will develop an automated method to score the severity of ocular surface lesions in the disease.
Patients with a diagnosis of pSS will be included in the study, will undergo detailed ophtalmologic examination, and will then use a webapp, installed on their smartphone, to score their symptoms everyday during 3 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of pSS according to ACR/EULAR classification criteria
排除标准
- •patient does not possess a smartphone with web connection
- •patient unable to sign an informed consent
结局指标
主要结局
Variability in the intensity of patient-reported symptoms
时间窗: 3 months
Variability over time (day-to-day assessment) of the ESSPRI score (dispersion of the values compared to the mean)
次要结局
- Interferometry(3 months)
- Tolerability of the daily use of a webapp to measure the symptoms(Month 3)
- Automated eye surface coloration measurement(3 months)