Therapeutic Contact Lenses vs. Tight Bandage Patching and Pain Following Pterygium Excision: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Measurment of pain and discomfort for patients post pterygium excision: Visual Analog Scale by questionnaire on marking straight horizontal line of fixed length from 0-100 mm where 0 mm is no pain and 100 mm is maximal pain.
研究概览
简要总结
This study is designed to determine the most effective post-operative care to relief the patient's discomfort after pterygium excision surgery.
详细描述
This is a prospective, randomized controlled trial. 50 patients with primary pterygium in both eyes for whom surgery was advised, will be recruited to the study. Criteria for pterygium excision surgery is mostly cosmetic, local eye symptoms, or visual impairment.
The following data will be collected and analyzed:
- Demographic data such as: age, gender
- Clinical data: best-corrected visual acuity (BCVA) full biomacroscopy examination, before surgery and at post-operative day (POD) 1 and 3
- Symptoms and discomfort: Visual Analogue Scale (VAS) score and pain killer use. The differences in these variables values preoperatively and on the first and 3rd postoperative day will compared between the two treated eyes.
Surgical technique and postoperative care
All patients will be operated for the same pterygium excision under local anesthesia in the formal accepted surgical method. All patients will be treated with ofloxacin drops + dexamethasone drops four times daily during the first postoperative week. The only difference is that one group will be bandaged with tight bandage patching and the other with therapeutic contact lenses (TCL) only for the first 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •healthy patients with no significant ocular diseases, older than 18 year old with both eyes pterygia, referred for surgery and which are interested of their own will for pterygium excision surgery.
排除标准
- •patients younger than 18 years old
- •patients with chronic diseases of the immune system
- •chronic diseases of eyelid or ocular surface, history of previous ocular surgery or trauma
- •collagen vascular disease or diabetes mellitus chronic
- •ingestion of pain killers.
结局指标
主要结局
Measurment of pain and discomfort for patients post pterygium excision: Visual Analog Scale by questionnaire on marking straight horizontal line of fixed length from 0-100 mm where 0 mm is no pain and 100 mm is maximal pain.
时间窗: 1st Post Operative Day and 3rd Post Operative Day
Assessing pain and discomfort comparing the two groups ( one with tight bandage and the other with contact lens).post pterygium excision by the change in pain scores on Visual Analog Scale.
次要结局
未报告次要终点
研究者
Dr Erez Tsumi
Head of Ophthalmology Department
Soroka University Medical Center