A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change of Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to traditional laser therapy in central serous chorioretinopathy.
详细描述
Central serous chorioretinopathy (CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity. Some studies have shown that traditional laser treatment (TLT) is effective on CSC, although accompanied with side-effects, such as scar. Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between TLT and MPL.
The study is the first prospective randomized controlled trial about 577nm micropulse laser versus traditional laser treatment in central serous chorioretinopathy. It is a noninferiority study. The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity.This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment. The primary outcome measures is the change of BCVA in 12 week.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients with CSC；
- •age>=18 years old;
- •Duration is less than 6 months；
- •the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT), and CRT>=250um;
- •active leakage located at ring 2 and ring 3 (ETDRS rings) on fluorescein angiography (FA).
排除标准
- •Patients with no case of CSC；
- •Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration；
- •Patients with prior retinal treatment less than 3 months；
- •Inability to obtain photographs or to perform FA
研究组 & 干预措施
577-MPL
577nm subthreshold micropulse laser(577-MPL) will be performed on the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein. Multiple laser spots will be applied, covering the leakage area. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um.
干预措施: 577-MPL (Device)
TLT
Traditional laser will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Traditional laser spots will be applied, covering the leakage area. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um.
干预措施: TLT (Device)
结局指标
主要结局
Change of Best Corrected Visual Acuity (BCVA)
时间窗: 12 week
ETDRS BCVA
次要结局
- the number of patients without any subretinal fluid (SRF)(3 week, 7 week, 12 week)
- Change of the central retinal thickness (CRT)(3 week, 7 week, 12 week)
- laser scar in area lasered on(12 week)
- the number of patients need retreatment(12 week)
研究者
Xiaoling Liu
professor
The Eye Hospital of Wenzhou Medical University