Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser 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
- 110
- 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
Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger patients. It is characterized by serous detachment of the neurosensory retina with or without serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be treated with traditional laser photocoagulation, but it has the side effects of causing RPE atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment but it's more than most families can afford to pay because of the high cost, what's more, it is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium (RPE) atrophy and RPE rip.
To date there is no international consensus on the optimal treatment of CSC Many retrospective studies suggest that micropulse laser (MPL) therapy may also be effective without obvious complications in this disease.
The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute central serous chorioretinopathy compared with the traditional laser coagulation.
详细描述
The study is a prospective randomized controlled trial about 577nm micropulse laser versus traditional laser coagulation therapy on acute central serous chorioretinopathy. The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid 3 months 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
- Double (Participant, 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
研究组 & 干预措施
577-MPL
577nm micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area.
干预措施: 577-MPL (Device)
577-TL
577nm Traditional laser(577-TL) 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.
干预措施: 577-TL (Device)
结局指标
主要结局
the proportion of eyes with complete absorption of subretinal fluid (SRF)
时间窗: 3 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 Best Corrected Visual Acuity (BCVA)(1months,3 months and 6 months)
- Change of fundus autofluorescence(1months,3 months and 6 months)
- Change in 10° retinal sensitivity(baseline,1months,3 months and 6 months)
研究者
Jin Chen-jin
Dr
Sun Yat-sen University