Prospective Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the proportion of eyes with complete absorption of subretinal fluid(SRF)
研究概览
简要总结
The purpose of this study is to determine whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute 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 Half-dose photodynamic therapy(PDT) is effective on CSC,although accompanied with side-effects,such as choroidal ischemia, retinal pigmental epithelium(RPE) atrophy,and RPE rip,and with exorbitant price.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 PDT and MPL.
The study is the first prospective randomized controlled trial about 577nm micropulse laser versus half-dose photodynamic therapy on acute central serous chorioretinopathy.The null hypothesis of the study is that there is difference between MPL and half-dose photodynamic therapy on acute central serous chorioretinopathy at first month after treatment.The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1 month after treatment.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •onset for the first time, as an episode duration of less than 6 months
- •patient was between 18 and 55 years of age
- •the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
- •active fluorescein leakage during fluorescein angiography (FA)
- •best corrected visual acuity (BCVA) more than 0.1, and less than 1.0
排除标准
- •previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
- •other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
- •retinal atrophy
- •inability to obtain photographs or to perform FA
- •use of steroid systemically or topically in the last 6 months
结局指标
主要结局
the proportion of eyes with complete absorption of subretinal fluid(SRF)
时间窗: 1 month
The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images
次要结局
- Change of fundus autofluorescence(1 month, 3 month, 6 month)
- Change of Best Corrected Visual Acuity(BCVA)(1 month, 3 month, 6 month)
- Change in 10°retinal sensitivity(1 month, 3 month, 6 month)
- the proportion of eyes with complete absorption of subretinal fluid(SRF)(6 month)
研究者
Jin Chen-jin
Dr
Sun Yat-sen University