Evaluation of the Clinical Efficacy of Hyaluronic Acid and Gingko Biloba Eyedrops in the Management of Iatrogenic Dry Eye Disease Induced by Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
Cataract surgery is one of the main causes of Dry Eye Disease (DED). This paper aimed at evaluating the prevalence of iatrogenic DED on a population of patients without DED receiving cataract surgery, and the impact of an eyedrop containing hyaluronic acid and gingko biloba (HA-GB, Trium free eyedrops, Sooft srl, Italy).
In this phase-IV trial we enrolled 40 patients with no DED. Patients were seen at baseline, day 1, week 1 and week 4. At each visit patients received Ocular Surface Disease Index (OSDI) questionnaire, Anterior segment ophthalmoscopy with grading of conjunctival hyperemia, fluorescein tear break-up time (TBUT), grading of fluorescein corneal staining (epithelial damage); adherence and tolerability using a visual analogue scale were checked at week 1 and 4.
At day 0 patients underwent cataract surgery (2.4 mm temporal incision) and were randomized to standard postoperative care (control group) or standard postoperative care + HA-GB given three times a day for 4 weeks (HA-GB group).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: Changes occurring between Day 1 vs Week 1 and Week 4
A score ranging from 0 to 100 calculated by means of a questionnaire
Tear Break-up time (TBUT), seconds
时间窗: Changes occurring between Day 1 vs Week 1 and Week 4
The time (seconds) from blinking from the first break of the tear film stained with fluorescein and evaluated at the slit lamp with blue cobalt filter and 10x magnification
次要结局
- Judgement of quality of study medications(Week 1, Week 4)
- Number of patients with TBUT of 5 sec or less(Changes occurring between Day 1 vs Week 1 and Week 4)
- Number of patients with corneal epithelial staining(Changes occurring between Day 1 vs Week 1 and Week 4)
- Conjunctival hyperemia(Changes occurring between Day 1 vs Week 1 and Week 4)
研究者
Paolo Fogagnolo
Principal Investigator, Clinical Professor
University of Milan