Early Transconjunctival Needling Revision With 5-fluorouracil Versus Medical Treatment in Encapsulated Blebs: a 12-month Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
When the glaucoma filtering surgery failures (intraocular pressure rises again), the options is start to use the hypotensive eye drops again (medical treatment). However, in some cases (encapsulated blebs), there is a simple surgical revision that can revival the primary failure surgery. It calls transconjunctival needling revision. In this study, the investigators compare the efficacy of this revision versus medical treatment in 12-month follow up in eyes with encapsulated blebs.
详细描述
To compare the efficacy of transconjunctival needling revision (TNR) with 5-fluorouracil versus medical treatment (MT) in glaucomatous eyes with uncontrolled intraocular pressure (IOP) due to encapsulated bleb after trabeculectomy Prospective, randomized, interventional study. A total of forty eyes of 39 patients with elevated IOP and encapsulated bleb diagnosed at maximum 5 months after primary trabeculectomy with mitomycin C were included. The eyes were randomized to either TNR with 5-fluorouracil or MT (hypotensive eyedrops). A maximum of two TNR per patient was allowed in the needling arm. All eyes were followed up for 12 months. Success of treatment was defined as IOP ≤ 18mmHg and 20% reduction from baseline at last follow up.
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
- •Eyes with encapsulated blebs developed in 5 months or less following primary glaucoma filtering surgery (trabeculectomy) and intraocular pressure >= 20mmHg
排除标准
- •Previous other ocular surgery
研究组 & 干预措施
Transconjunctival needling revision
Eyes with primary glaucoma surgery failure with encapsulated bleb submitted to surgical revision
干预措施: Transconjunctival needling revision (Procedure)
Medical treatment
Eyes with primary glaucoma surgery failure with encapsulated blebs were treated with medical treatment (hypotensive eye drops)
干预措施: Medical treatment (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: 12 months
次要结局
未报告次要终点
研究者
Ricardo Suzuki
Assistant professor of Ophthalmology at HCFMUSP
University of Sao Paulo General Hospital