Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Intraocular Pressure (IOP) Change
研究概览
简要总结
The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).
详细描述
SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.
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
- Triple (Participant, Care Provider, Investigator)
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
- •clinical diagnosis of glaucoma
- •clinician has determined that SLT laser is indicated
- •IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)
排除标准
- •prior history of uveitis
- •prior glaucoma surgery including glaucoma laser surgery
- •pregnant or 3 months post-partum
研究组 & 干预措施
Artificial Tears
Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
干预措施: Artificial Tears (Drug)
Non-steroidal anti-inflammatory
Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
干预措施: Ketorolac (Drug)
Steroid
Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
干预措施: Prednisolone 1% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) Change
时间窗: Baseline to Week 12
IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.
次要结局
- Intraocular Inflammation(Up to week 12)
研究者
Jeffrey L Goldberg
Professor of Ophthalmology
Stanford University