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临床试验/NCT04254536
NCT04254536Unknown不适用

Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema Before and After Treatment With Conbercept

Renmin Hospital of Wuhan University0 个研究点目标入组 35 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
35
主要终点
central retinal thickness(CRT)

研究概览

简要总结

Eyes with diabetic macular edema requiring conbercept treatment will be followed up for one month. Before treatment, one week after treatment and one month after treatment, the eyes will be examined by optical coherence tomography (OCT) and optical coherence tomographic angiography (OCTA). The changes of macular edema will be observed and analyzed by OCT leakage mapping software, and the relationship between the changes of macular edema and visual acuity will be analyzed.

详细描述

  1. Research purpose:

After one month follow-up, we will observe whether OCTleakage mapping can be used as a biomarker to predict the prognosis of DME eyes, and will observe the effect of Conbercept on improving edema and visual acuity of DME eyes. 2. Subjects Number of subjects planned to be recruited: 35

Inclusion criteria:

  1. Age ≥ 18
  2. Diabetic macular edema eyes treated with conbercept for the first time in 1 week
  3. Informed consent of patients and signing of informed consent

Exclusion criteria:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic macular edema eyes treated with conbercept for the first time in 1 week
  • Informed consent of patients and signing of informed consent

排除标准

  • 1)Myopia ≥ 6.0D
  • Macular diseases affecting vision
  • Vitreous hemorrhage requiring surgery
  • Patients with anterior segment neovascularization
  • Eye or periocular infection
  • Optic neuropathy and glaucoma
  • Periphlebitis, ophthalmic ischemic syndrome, uveitis, coat's disease, FEVR and other retinal diseases
  • Ametropia and cataract surgery
  • In 3 months, in addition to this treatment of conbercept, other anti VEGF treatment, laser treatment or vitreoretinal surgery were performed
  • Other systemic diseases can not complete follow-up

结局指标

主要结局

central retinal thickness(CRT)

时间窗: 2020-12

CRT will be measured by OCT software and the changes before treatment, 1 week after treatment and 1 month after treatment will be compared

low optical ratio(LOR)

时间窗: 2020-12

The image will be processed by OCT leakage mapping software, and the changes of LOR will compared before treatment, 1 week after treatment and 1 month after treatment

best corrected visual acurity(BCVA)

时间窗: 2020-12

Compare the changes of BCVA before treatment, 1 week after treatment and 1 month after treatment

次要结局

  • Ellipsoid Zone(2020-12)

研究者

申办方类型
Other
责任方
Sponsor

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