Bromfenac Ophthalmic Solution 0.1% for Postoperative Ocular Pain and Inflammation Related To Pterygium Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- visual analog scale(VAS)
研究概览
简要总结
To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.1% dosed twice daily for the treatment of ocular inflammation and pain after pterygium excision with amniotic membrane transplantation(AMT).
详细描述
Patients scheduled to undergo pterygium excision with AMT were randomized to receive added topical bromfenac or artificial lacrima at 3 days before and 7 days after the surgery. Pain intensity was evaluated with the visual analog scale(VAS) and present pain index(PPI) with the short form of the McGill Pain Questionnaire. psychological state used Self-rating of Depression Scale(SDS) and Self-rating of Anxiety Scale (SAS) to assess. Ocular inflammation was assessed with an automated bulbar redness grading technique. The irritative symptoms evaluation was carried out by an independent investigator at each visit with questionnaires of ocular symptom scores(OSS). Corneal epithelial healing rate was calculated after following up. All patients had follow-ups at the day 1, day 3, day7 and day 10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 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
研究组 & 干预措施
Artificial tears
0.1% bromfenac VS Artificial tears
干预措施: 0.1% bromfenac (Drug)
结局指标
主要结局
visual analog scale(VAS)
时间窗: Change from Baseline VAS at 10 days
The VAS pain score provides an intensity score of the pain experienced. The VAS allows the patient to self-rate his or her pain on a 0 to 10 horizontal grading scale of subjective pain assessment with 0 as "no pain at all" and 10 being "the most severe intolerable pain I have ever experienced."
present pain intensity index(PPI)
时间窗: Change from Baseline PPI at 10 days
The PPI scale is a measure of the magnitude of pain experienced by an individual and is a six-point verbal rating scale that indicates overall pain intensity and includes six levels (0, none; 1, mild; 2, discomforting; 3, distressing; 4, horrible; and 5, excruciating). Higher numbers indicate more severe pain.
次要结局
- Inflammation Evaluation by temporal conjunctival hyperaemia index (TCHI)(Change from Baseline TCHI at 10 days)
- Symptoms Evaluation by ocular symptom scores(OSS)(Change from Baseline OSS at 10 days)
- corneal epithelium healing(CEH)(Change from Baseline corneal epithelial defect at 10 days)
- psychological state changes of anxiety was evaluated with Self-rating Anxiety Scale(SAS)(Change from Baseline SAS at 10 days)
- psychological state changes of depression was evaluated with Self-rating Depression Scale(SDS)(Change from Baseline SDS at 10 days)
研究者
Jin Yuan
Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University