A Randomized Clinical Trial: Comparison of the Efficacy of Topical 0.2% Loteprednol Etabonate and Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 主要终点
- rate of true recurrent pterygium
研究概览
简要总结
The objective of this study was to evaluate the efficacy of topical 0.2% loteprednol etabonate, a 'soft steroid', compared with topical 0.1% dexamethasone, which is widely used in postoperative pterygium excision to prevent the recurrence of pterygium. If 0.2% loteprednol etabonate is non-inferior in efficacy compared with 0.1% dexamethasone, it may be used postoperatively in pterygium excision patients with the benefit of a low incidence of ocular hypertension or secondary glaucoma.
详细描述
A prospective randomized control trial was performed from October 2015 to April 2019 at the Department of Ophthalmology, Thammasat Hospital, Thailand and Panyananthaphikkhu Chonprathan Medical Center, Thailand.
Subjects Patients who had pterygium excision with amniotic membrane transplantation (AMT) and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea were included.
Then the participants were randomized into 2 groups. Both groups received subconjunctival 5-fluorouracil (5-FU) injection 5mg/0.1 mL with 27-gauge needle in the area of fibrovascular tissue, and then the eyes were irrigated with 30 mL of normal saline. 0.2% loteprednol etabonate was prescribed in group 1, and 0.1% dexamethasone (CD-oph) was prescribed in group 2 every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months. 5-FU was repeatedly injected monthly in the presence of marked inflammation and not more than 3 times to prevent complications.
All patients were followed-up at 1, 3, 6, and 9 months to assess the impending recurrent pterygium severity score, intraocular pressure, complications, detection of true recurrent pterygium, and time to recurrence.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who had pterygium excision with amniotic membrane transplantation and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea
排除标准
- •recurrent pterygium
- •received adjunctive treatment with beta radiation, mitomycin C or 5-fluorouracil
- •glaucoma or intraocular pressure > 21 mmHg
- •history of 5-fluorouracil or chloramphenicol allergy
研究组 & 干预措施
0.2% loteprednol etabonate
This group was treated with subconjunctival 5-FU injection and topical 0.2% loteprednol etabonate every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
干预措施: 0.2% loteprednol etabonate (Drug)
0.1% dexamethasone
This group was treated with subconjunctival 5-FU injection and topical 0.1% dexamethasone (CD-oph) every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
干预措施: 0.1% dexamethasone (Drug)
结局指标
主要结局
rate of true recurrent pterygium
时间窗: 6 months
true recurrent pterygium is the fibrovascular tissue that invade into cornea
次要结局
- time to recurrent of pterygium(6 months)
- severity score of impending recurrent pterygium(6 months)
- rate of steroid induced ocular hypertension(6 months)
研究者
Wannisa Suphachearabhan
Principal investigator
Srinakharinwirot University