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临床试验/NCT06518096
NCT06518096已完成不适用

Prediction Model of Microvascular Ischemic Ocular Motor Nerve Palsy and Inflammatory Ocular Motor Nerve Palsy in Chinese Patients

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 299 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
状态
已完成
发起方
入组人数
299
试验地点
1
主要终点
The diagnosis of acute bilateral diplopia, microvascular ischemic ocular motor nerve palsy or inflammatory ocular motor nerve palsy.

研究概览

简要总结

This study aimed to train and validate deep learning systems (DLS) to differentiate between microvascular ischemic ocular motor nerve palsy (v-OMNP) and inflammatory ocular motor nerve palsy (i-OMNP). The method involves using clearly diagnosed v-OMNP and i-OMNP patients from the Department of Neurology database at Beijing Tongren Hospital for further DLS validation, aiding in the differential diagnosis of the aforementioned diseases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients with acute bilateral diplopia within 1 week of onset at admission.
  • Ischemic Group:
  • Sudden onset of unilateral CN III, CN IV, or CN VI palsy.
  • Isolated CN III (without pupil involvement), CN IV, or CN VI palsy.
  • Presence of vascular risk factors (VRFs).
  • Significant symptom recovery no earlier than 2 months after onset, with complete (or nearly complete) recovery within 3-6 months.
  • Inflammatory Group:
  • Unilateral painful CN III, CN IV, and/or CN VI palsy.
  • Symptoms (including pain or diplopia signs) significantly improved within 72 hours after treatment with corticosteroids.
  • MRI of the cavernous sinus showing inflammation, i.e., abnormal widening/enhancement of the affected cavernous sinus with or without granulomatous changes/inflammatory manifestations of adjacent tissues.

排除标准

  • Ocular muscle palsy confirmed to be caused by tumors, trauma, infections, stroke, carotid-cavernous fistula, aneurysms, neuromuscular junction disorders, thyroid-related eye diseases, and hereditary diseases at onset or during follow-up.
  • Presence of other neurological signs in addition to ocular muscle palsy.
  • Severe systemic diseases of the heart, liver, or kidneys, as well as psychiatric and mental illness.
  • Pregnant or breastfeeding patients.
  • Patients who did not undergo gadolinium-enhanced MRI of the cavernous sinus.
  • Patients younger than 18 years at the time of enrollment.
  • Onset of symptoms more than 1 week before admission.
  • Incomplete data or follow-up period less than 6 months.
  • Disagreements in disease diagnosis.

结局指标

主要结局

The diagnosis of acute bilateral diplopia, microvascular ischemic ocular motor nerve palsy or inflammatory ocular motor nerve palsy.

时间窗: 6 months

This study aimed to train and validated deep learning systems to differentiate between v-OMNP and i-OMNP. Clinical information, including sex, age at onset, clinical manifestations, inflammatory factors (including C-reactive protein, erythrocyte sedimentation rate, autoimmune antibody in the cerebrospinal fluid), cavernous sinus MRIs, and prognosis, was obtained from hospitalization and follow-up records. The following information was recorded: (1) intracavernous sinus: abnormal side, thickness of cavernous sinus, thickening enhancement, enlargement and enhancement of CN III, CN IV and CN VI, and narrowing of intracavernous internal carotid artery and (2) extracavernous sinus: enhancing adjacent lesions, lacrimal prolapsus, orbital fascial lipocele, eyeball protrusion, thickened eyelids, and dilatation of superior orbital veins.

次要结局

未报告次要终点

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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