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临床试验/NCT04257734
NCT04257734Unknown不适用

Epidemiologic and Clinical Characteristics of Optic Neuritis in China

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Visual Acuity

研究概览

简要总结

This will be a hospital-based retrospective multi-center study on epidemiologic and clinical characteristics of optic neuritis among Chinese. The investigation will cover about 29 provinces or municipalities all around China.

详细描述

This national investigation will be conducted to describe the epidemiology and clinical characteristics of optic neuritis in China. All the patients will be divided into 3 groups according to the serum demyelinating antibodies (Aquaporin-4 antibody seropositive group, Myelin oligodendrocyte glycoprotein antibody seropositive group and double seronegative group). The investigator will analyze the differences among the three groups.

Primary outcomes:

  • To dig out the different visual acuity (VA, LogMAR) prognosis among the three groups;

  • To calculate the annual relapse rate (ARR) differences among the three groups (relapse times in all the follow-up time in each group/ follow-up time (years) in all in each group).

Secondary outcomes:

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of optic neuritis
  • The patients' medical records were complete

排除标准

  • Patients with unclear diagnosis of optic neuritis
  • Incomplete medical records

结局指标

主要结局

Visual Acuity

时间窗: At least 1 year from the attack to the final visit

Last visual acuity records in the hospital

Annual Relapse Rate

时间窗: At least 1 year from the attack to the final visit

Calculated annual relapse rate of different subgroups in the cohort

次要结局

  • Clinical characteristics of optic neuritis(At least 1 year from the attack to the final visit)
  • Orbit or Brain MRI at the attack(At least 1 year from the attack to the final visit)
  • Optical Coherence Tomography(At least 1 year from the attack to the final visit)
  • Epidemiologic characteristics of optic neuritis(At least 1 year from the attack to the final visit)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Shihui

Professor

Chinese PLA General Hospital

研究点 (1)

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