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临床试验/NCT03497000
NCT03497000已完成不适用

Effects of Optical Coherence Tomography Angiography-guided Photodynamic Therapy in Acute Central Serous Chorioretinopathy

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Number of patients with subretinal fluid resolution on OCT after PDT of two groups

研究概览

简要总结

OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
  • Presence of SRF and/or serous pigment epithelial detachment on OCT
  • Presence of abnormal dilated choroidal vasculature in ICGA

排除标准

  • Patients with other ocular conditions commonly associated with SRF, such as choroidal neovascularization, polypoidal choroidal vasculopathy (PCV), diabetic retinopathy, retinal vascular occlusion, Coat's disease
  • Any disease that may affect the quality of imaging (quality of OCTA images < 6), such as cataract, high myopia or nystagmus
  • History of ocular surgeries including retinal laser
  • Pregnancy
  • Any uncontrolled systemic disease
  • Any condition rendering patients intolerable to image acquisition

研究组 & 干预措施

OCTA group

Experimental

Patients in this group underwent OCTA-guided half-dose photodynamic therapy.

干预措施: OCTA-guided Photodynamic therapy (Procedure)

ICGA group

Active Comparator

Patients in this group underwent normal ICGA-guided half dose photodynamic therapy.

干预措施: ICGA-guided Photodynamic therapy (Procedure)

结局指标

主要结局

Number of patients with subretinal fluid resolution on OCT after PDT of two groups

时间窗: 3 months

次要结局

  • BCVA (best corrected visual acuity) at every follow-up of two groups(1 month, 3 months)
  • Number of patients with leakage point resolution on FFA after PDT of two groups(3 months)
  • Number of recurrent CSC after PDT of two groups(3 months)

研究者

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

Mingwei Zhao

Head of Ophthalmology, Professor

Peking University People's Hospital

研究点 (1)

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