Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Chinese Primary Angle Closure Glaucoma
试验速览
- 阶段
- 不适用
- 入组人数
- 246
- 主要终点
- success rate of IOP reduction
研究概览
简要总结
To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in Chinese PACG .
详细描述
A randomized, single blind, positive parallel control study method was used.This prospective case series will recruit 246 Chinese POAG, 123 cases in the experimental group will receive AIT treatment and 123 cases in the control group will receive trabeculectomy(Trab) surgery.Measurements of intraocular pressure(IOP) , visual acuity, refraction, slit lamp examination of the anterior segment and fundus, optical coherence tomography(OCT) to detect retinal nerve fiber layer thickness, macular thickness, visual field, gonioscopy and ultrasonic biological microscopy (UBM) will be recorded.They will be followed up for 12 months. The main outcome is success rate of IOP reduction and the other outcome are the number of antiglaucoma medication and complications .
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 (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
- •Primary Angle Closure Glaucoma (PACG) with visible trabecular meshwork from 90︒ to 180︒ on gonioscopy and IOP couldn't be controlled ≤21mmHg with pilocarpine eye drop only.
- •willing to accept the antiglaucoma surgery
- •volunteer to participate in this study and be able to follow up on time
- •previous antiglaucoma filtering surgery or laser surgery(LPI, SLT) and previous cataract surgery were not ruled out
排除标准
- •visual acuity lower than HM or central tubular visual field
- •corneal edema or large pterygium affecting the observation of anterior angle
- •the demarcation of the scleral process and trabecular meshwork is not clear on gonioscopy
- •new vessels on the iris surface or in the anterior angle chamber
- •the eye received surgery is the only eye with visual function, that is the contralateral eye is blind
- •requiring long-term use of anticoagulant drugs for systemic reasons
- •abnormal coagulation function
- •with specific clear scar physique
- •cannot participate in follow-up
研究组 & 干预措施
AIT group
PACG in AIT group will receive ab interno trabeculectomy with Trabectome and before AIT, Laser Peripheral Iridectomy (LPI) will be performed first.
干预措施: ab interno trabeculectomy with Trabectome (Procedure)
Trab group
PACG in AIT group will receive trabeculectomy.
干预措施: trabeculectomy (Procedure)
结局指标
主要结局
success rate of IOP reduction
时间窗: 12 months
IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery
次要结局
- 24-hour IOP fluctuations(12 months)
- number of antiglaucoma medication(12 months)
- complication rate(12 months)