A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma
试验速览
- 阶段
- 1 期
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months
研究概览
简要总结
The aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma.
详细描述
End-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. A common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. This study specifically aims to compare the intraocular pressure (IOP) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.The hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •· More than 21 years old
- •Advanced glaucoma refractory to maximum tolerated medical and surgical treatment
- •Visual acuity worse than 6/60
- •Poor candidates for additional filtration surgery
排除标准
- •· Any eye surgery done within 2 months of enrolment
- •Any ocular infection or inflammation
- •Unable to give informed consent
结局指标
主要结局
Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months
次要结局
- Number of patients with complications, such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage