跳至主要内容
临床试验/NCT02799992
NCT02799992Unknown不适用

Pseudo-PDT in Central Serous Chorioretinopathy

Università degli Studi di Brescia0 个研究点目标入组 22 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
22
主要终点
Central Retinal Thickness (micron)

研究概览

简要总结

Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients, characterized by serous retinal detachment in the macular region. We evaluated half-dose verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.

Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography findings were compared between groups.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥18 years;
  • patients with best-corrected visual acuity (BCVA) of 20/200 or better;
  • presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment involving the fovea on optical coherence tomography (OCT);
  • presence of active angiographic leakage in fluorescein angiography caused by CSC and no other diseases, and abnormal dilated choroidal vasculature and other features in indocyanine green angiography (ICGA) consistent with the diagnosis of CSC.

排除标准

  • any previous treatment for CSC;
  • evidence of choroidal neovascularization or other maculopathy on fundus examination.

结局指标

主要结局

Central Retinal Thickness (micron)

时间窗: 6 months

Measured with OCT

Subfoveal Choroidal Thickness (micron)

时间窗: 6 months

Measured with OCT

Best-corrected Visual Acuity (LogMAR)

时间窗: 6 months

Measured with ETDRS chart

次要结局

  • Ellipsoid Zone Recovery (integrity of IS/OS line)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Russo

MD, PhD Candidate

Università degli Studi di Brescia

相似试验