Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Effectiveness of both modification for the treatment of chronic CSCR Fluorescent leakage as regards to BCVA OCT changes
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness as well as the detrimental influence of half-dose and half-fluence modification of verteporfin photodynamic therapy (PDT) for the treatment of prolonged unresolved central serous chorioretinopathy (CSCR).
详细描述
Purpose:
to evaluate the effectiveness as well as the detrimental influence of half-dose and half-fluence modification of verteporfin PDT for the treatment of prolonged unresolved Central Serous Chorioretinopathy (CSCR).
Study Design and Patient Recruitment:
This study was a prospective, randomized, consecutive, open-labeled, comparative interventional case series. Patients with symptomatic acute or chronic CSC of 3 weeks or more duration were recruited. Patients were offered treatment if they had worsening of symptoms or no subjective improvement since the onset of the CSC. Inclusion criteria included 1) patients with best-corrected visual acuity (BCVA) of 20/400 or better; 2) presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment (PED) involving the fovea on optical coherence tomography (OCT); 3) presence of active angiographic leakage in fluorescein angiography (FA) caused by CSC but not CNV or other diseases; and 4) abnormal dilated choroidal vasculature and other features in ICGA consistent with the diagnosis of CSC. Patients who received previous PDT or focal thermal laser photocoagulation for the treatment of CSC or had evidence of CNV, polypoidal choroidal vasculopathy, or other maculopathy on clinical examination, FA, or ICGA were excluded. Informed consent was obtained from all subjects. 12 patients in each group were planned to recruit in each group.
Modified Photodynamic Therapy with Half Dosage:
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with best-corrected visual acuity (BCVA) of 20/200 or better
- •Presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment (PED) involving the fovea on optical coherence tomography (OCT)
- •Presence of active angiographic leakage in fluorescein angiography (FA) caused by CSC but not CNV or other diseases
- •Abnormal dilated choroidal vasculature and other features in ICGA consistent with the diagnosis of CSC.
排除标准
- •Patients who received previous PDT or focal thermal laser photocoagulation for the treatment of CSC.
- •Patients had evidence of CNV, polypoidal choroidal vasculopathy, or other maculopathy on clinical examination, FA, or ICGA
研究组 & 干预措施
verteporfin PDT, half-dose
use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy
干预措施: Verteporfin PDT, half-dose (Drug)
verteporfin PDT, half-dose
use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy
干预措施: verteporfin PDT, half-fluence (Drug)
verteporfin PDT, half-fluence
use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy
干预措施: Verteporfin PDT, half-dose (Drug)
verteporfin PDT, half-fluence
use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy
干预措施: verteporfin PDT, half-fluence (Drug)
结局指标
主要结局
Effectiveness of both modification for the treatment of chronic CSCR Fluorescent leakage as regards to BCVA OCT changes
时间窗: within 6 months
次要结局
- Detrimental influence on choroidal perfusion Represented by the decrease of fluorescent intensity In ICGA(within 6 months)
