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

Completed

• Conditions: Neuro-Ophthalmology

• Registration Number: NCT06518096
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-07-31
• Study Completion: 2024-04-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-21
• Last Update Submitted: 2024-07-21
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

• Patients with acute bilateral diplopia within 1 week of onset at admission.

  1. Ischemic Group:

  2. Sudden onset of unilateral CN III, CN IV, or CN VI palsy.

  3. Isolated CN III (without pupil involvement), CN IV, or CN VI palsy.

  4. Presence of vascular risk factors (VRFs).

  5. Significant symptom recovery no earlier than 2 months after onset, with complete (or nearly complete) recovery within 3-6 months.

  6. Inflammatory Group:

  7. Unilateral painful CN III, CN IV, and/or CN VI palsy.

  8. Symptoms (including pain or diplopia signs) significantly improved within 72 hours after treatment with corticosteroids.

  9. 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.

     2. 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.

     3. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tongren Hospital; 🇨🇳 Beijing, Beijing, China