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临床试验/NCT05390619
NCT05390619Unknown不适用

Comparison of Different Doses of Verteporfin Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
The complete absorption rate of subretinal fluid

研究概览

简要总结

This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. The primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (OCT), and then the best PDT treatment scheme for chronic CSC was summarized.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 years old, regardless of gender;
  • Meet the diagnostic criteria of central serous chorioretinopathy;
  • The course of CSC (subject to the symptoms of this disease) is more than 3 months;
  • Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.

排除标准

  • macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases;
  • a previous history of PDT treatment;
  • systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.

结局指标

主要结局

The complete absorption rate of subretinal fluid

时间窗: 3 months after the primary PDT

The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit

次要结局

  • Best corrected visual acuity change after the PDT(12 months after the PDT)
  • Subfoveal choroidal thickness change after the PDT(12 months after the PDT)
  • Central foveal thickness change after the PDT(12 months after the PDT)

研究者

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

Yao Yiou

Principal Investigator

Peking University People's Hospital

研究点 (1)

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