Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,033
- 试验地点
- 1
- 主要终点
- OSDI Score
研究概览
简要总结
This study assessed the differences in DED symptomatology measured with the OSDI questionnaire regarding climate data of the geographic location in a large population in Spain, with a special focus on the relative humidity (RH) of the place of residence and the impact of artificial tears use, to help eye care practitioners in patient management and education
详细描述
This was a multicentre study enrolling patients to attend primary eye care centres of the EMO research group across 12 different Spanish locations. A comprehensive eye examination was performed in all participants. Dryness symptomatology was assessed with OSDI questionnaire. In subjects with dryness symptomatology (OSDI questionnaire score between 13 and 32) were prescribed to use high molecular weight HA-based artificial tears (DISOP Inc, Spain) along three months), instilled 3 times per day.
Additionally, the daily mean, minimum, and maximum values of the climate data for five different variables [skin temperature (°C), wind gusts (m/s), air temperature (°C), atmospheric pressure (Pa) and RH (%)] corresponding to the visit date were collected from the EU-funded Copernicus Climate Change Service and the 5-year average RH values published by the Spanish meteorological agency.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher of each center
排除标准
- •Hyperthyroidis
- •Rheumatism
- •Autoimmune disease
- •Previous diagnosis of Dye Eye Disease
- •Cicatricial conjunctivitis
- •Pterygium
- •Eyelid trichiasis
- •History of any eye medication use in the last 3 months to treat any eye condition (glaucoma, etc.)
- •Active anterior eye inflammation (such as blepharitis, conjunctivitis, keratitis, scleritis, uveitis, etc.)
- •Use of contact lenses in the last 3 months
- •Previous ocular trauma or surgery in the last 6 months.
结局指标
主要结局
OSDI Score
时间窗: three months
Change in the Ocular Surface Disease Index (OSDI) score ranged from 0 (asymptomatic) to 100 (severe dry eye)
次要结局
未报告次要终点
研究者
Raul Martin Herranz
PhD
University of Valladolid