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OpenTrials
Completed

NCT Number: NCT06518096

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongren Hospital

Beijing, Beijing Municipality, 102600, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The diagnosis of disease is the outcome of the study. The inclusion criteria and exclusion criteria were as follows:

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 1. 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. 3. Severe systemic diseases of the heart, liver, or kidneys, as well as psychiatric and mental illness.
  • Pregnant or breastfeeding patients. 5. Patients who did not undergo gadolinium-enhanced MRI of the cavernous sinus. 6. Patients younger than 18 years at the time of enrollment. 7. Onset of symptoms more than 1 week before admission. 8. Incomplete data or follow-up period less than 6 months. 9. Disagreements in disease diagnosis.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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