A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT
试验速览
- 阶段
- 3 期
- 入组人数
- 139
- 试验地点
- 14
- 主要终点
- Intraocular Pressure
研究概览
简要总结
Lasers are important therapy in glaucoma. They are a pivotal point in treatment between medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used: argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT including causing less damage to the tissue it affects. One of the potential patient centered benefits of this laser is that it may be repeatable. It is even possible that the old laser ALT may be useable after an SLT treatment. This study aims to uncover whether repeat laser is possible after SLT and if so which laser is more effective (ALT vs SLT). The potential of repeating laser therapies may delay surgical treatment and its complications. Also understanding which laser to use will help eye doctors know how to treat their patients at this point of the disease.
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
- Single (Participant)
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
- •Over age of 18 yo.
- •OAG including pigmentary dispersion syndrome and pseudoexfoliation
- •OAG has been treated with 360 degrees of SLT
- •two sighted eyes,
- •willing to participate after being informed of and reading the patient information material.
排除标准
- •Narrow angle glaucoma
- •Previous glaucoma surgery
- •Eye surgery expected in the next 12 months
- •Severe corneal disease
- •On or anticipated steroid in 6 months
- •Pregnant or breast feeding
研究组 & 干预措施
Argon laser trabeculoplasty
Up to the year 2005, the vast majority of ophthalmologists used Argon laser trabeculoplasty (ALT) as the mode of laser therapy. ALT is effective but its most significant problem is that its effectiveness decreases with re-treatment since the tissue it targets (the trabecular meshwork) is changed by the laser rendering repeat treatments less effective.
干预措施: Argon laser trabeculoplasty (Procedure)
Argon laser trabeculoplasty
Up to the year 2005, the vast majority of ophthalmologists used Argon laser trabeculoplasty (ALT) as the mode of laser therapy. ALT is effective but its most significant problem is that its effectiveness decreases with re-treatment since the tissue it targets (the trabecular meshwork) is changed by the laser rendering repeat treatments less effective.
干预措施: Selective laser trabeculoplasty (Procedure)
selective laser trabeculoplasty
Post 2005, a newer mode of laser therapy, selective laser trabeculoplasty (SLT) has emerged as the standard of care laser. There are many potential advantages to SLT but to date these advantages are only theoretical. The most important potential clinical advantage of SLT is that it causes less damage to the tissue it targets.
干预措施: Argon laser trabeculoplasty (Procedure)
selective laser trabeculoplasty
Post 2005, a newer mode of laser therapy, selective laser trabeculoplasty (SLT) has emerged as the standard of care laser. There are many potential advantages to SLT but to date these advantages are only theoretical. The most important potential clinical advantage of SLT is that it causes less damage to the tissue it targets.
干预措施: Selective laser trabeculoplasty (Procedure)
结局指标
主要结局
Intraocular Pressure
时间窗: 12 months post operatively
IOP difference between baseline and 12 month post-laser.
次要结局
- To compare any adverse events between the two groups at all visits.(12 months)
- To compare the trabecular meshwork pigmentation between the groups at all visits.(12 months)
- To compare the IOP lowering effect between the groups at other postoperative visits(12 months)
- To compare the visual acuity between the groups at all visits.(12 months)
- SLT repeatability of long term follow up in glaucoma patients(36 months after initial enrollment of the primary study)
研究者
William Hodge
Professor of Department of Ophthalmology, Western University
Lawson Health Research Institute