Effect of Bioptron Light Therapy on Dryness of Eyes in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dry Eye-Related Quality-Of-Life Score (DEQS)
研究概览
简要总结
Dry eye disease (DED) is a growing public health concern affecting quality of life and visual function, with a significant socio-economic impact. It is more prevalent in the females and is being specifically in the menopausal and postmenopausal age group.
Bioptron light therapy is efficient in the elimination of allergic reactions, signs and symptoms of dry eye improving capillary circulation, immunity stimulation, relieving pain and establishing balance of tissue electromagnetic field
详细描述
Around 60 postmenopausal women will be randomly divided into two equal groups, they all complain from dry eye symptoms, ranging from mild/normal to moderate and severe.
Group(A): will receive patient education program for four weeks. Group(B): will receive patient education program and bioptron light therapy for four weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All participants are postmenopausal women.
- •Their age above 50 years old
- •All participants aren't on any systematic therapy.
排除标准
- •• Injuries and previous surgical treatment of eyes
- •All patients with diagnosis of chronic blepharitis, meibominitis or any other eye infections
- •Participants with autoimmune diseases such as Sjögren's syndrome (SS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE)
- •Diabetic participants will be excluded.
- •Smokers will be excluded from the study.
- •The use of Hormone Replacement Therapy
结局指标
主要结局
Dry Eye-Related Quality-Of-Life Score (DEQS)
时间窗: Dry Eye-Related Quality-Of-Life Score will be measured at baseline, and it will be measured again after four weeks
The Dry Eye-Related Quality-Of-Life Score questionnaire is a 15-item instrument for assessing subjective dry eye symptoms and their effects on activities of daily living within the previous week. 1. extremely good 2. very good 3. good 4. bad 5. very bad 6. extremely bad
Tear Breakup Time (TBUT)
时间窗: Tear Breakup Time will be measured at baseline, and it will be measured again after four weeks
Tear Breakup Time Is the time interval between a complete blink and the appearance of the first break, discontinuity or dry spot observed in the tear film.
次要结局
- Schirmer's test(Schirmer's test will be measured at baseline, and after four weeks)
研究者
Alaa Mohamed El-Moatasem Mohamed
lecturer of physical therapy
Cairo University