Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative Dry Eye Syndrome After Cataract Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
Dry eye disease (DED) is a multifactorial condition often exacerbated by cataract surgery, leading to discomfort and visual disturbances. Meibomian gland dysfunction (MGD), a key cause of DED, contributes to tear film instability, which can be managed with warm compress therapy.
详细描述
This study aims to evaluate the effectiveness of perioperative warm compress therapy (TPT) in improving tear film stability and reducing dry eye symptoms following cataract surgery. This randomized controlled trial (RCT) will involve 54 patients with estimated attrition rate 60 participants aged 50-70 with moderate to severe dry eye symptoms and tear film instability, as indicated by high Ocular Surface Disease Index (OSDI) scores. Participants will be randomly assigned to either an intervention group, receiving warm compress therapy before and after surgery, or a control group receiving standard dry eye treatments for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 30 to 70 years
- •Patients scheduled for cataract surgery (both unilateral and bilateral).
- •Patients with preoperative moderate to severe dry eye symptoms, which will be assessed using the Ocular Surface Disease Index (OSDI).
排除标准
- •Patients with OSDI, indicating severe dry eye disease which suggests severe dry eye disease. These patients might require more intensive treatments beyond Warm Compress therapy.
- •Patients with systemic diseases (e.g., rheumatoid arthritis, lupus) that affect tear production or who are using medications that severely reduce tear production (e.g., chronic use of antihistamines or systemic corticosteroids).
- •Patients with significant pre-existing corneal pathology (e.g., corneal dystrophies, corneal scars) that could affect the results of cataract surgery or thermal pulsation therapy.
- •Patients with active ocular infections (e.g., conjunctivitis, keratitis) or inflammation at the time of screening or surgery.
- •Patients with a history of previous ocular surgeries (excluding cataract surgery) in the study eye, such as refractive surgery (LASIK, PRK) or corneal transplants.
- •Patients with a known allergy or contraindication to Warm Compress therapy or its components.
研究组 & 干预措施
Warm Compress
干预措施: Warm Compress (Combination Product)
Standard Care
干预措施: Standard Care (Diagnostic Test)
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: 12 Months
The Ocular Surface Disease Index (OSDI) is a 12-question questionnaire used to assess the severity of dry eye symptoms and their impact on vision-related function, scored on a scale of 0 to 100, with higher scores indicating greater disability.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University