Clincosm LogoSign in Get a demo

Neuromuscular Ultrasonography Assessment of Optic Nerve in Systemic Lupus Eryhematosus

Sponsor
Amira M elSonbaty (Other)
Overall Status
Completed
CT.gov ID
NCT05853003
Collaborator
(none)
140
Enrollment
1
Location
15.9
Actual Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

assessing the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Evaluating the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.by measuring the diameter of optic nerve at certain site and comparing it to healthy subjects measurements and to asses NMUS ability to detect optic neuropathy in lupus patients in comparison to conventional techniques including opthalmologist evaluation and visual evoked potential

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    140 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Neuromuscular Ultrasonography Assessment of Optic Nerve in SLE
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Dec 31, 2022
    Actual Study Completion Date :
    Apr 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. comparing diameter of optic nerve in SLE patients and compare them to healthy subjects [over 1 year]

      comparing diameter of optic nerve in SLE patients and compare them to healthy subjects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adult

    • group of SLE patients, who fulfilled Systemic Lupus International Collaborating Clinics classification criteria for SLE (SLICC) with or without symptoms of optic neuropathy

    • another group of apparently healthy subjects with no. history of chronic conditions

    Exclusion Criteria:

    • Any patient with optic neuritis due to causes other than lupus was excluded from the study: ex.

    • Post traumatic neuropathy

    • Purely degenerative neuropathy

    • Diabetic neuropathy

    • Toxic neuropathy

    • Neuropathies related to infections

    • Drug induced neuropathy e.g: quinine and some antibiotics, ethambutol

    • Infections e.g. measles, mumps, Lyme disease, etc.

    • Other Autoimmune diseases like sarcoidosis, B.D

    • Tumor causing Inc. intracranial tension.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assuit university hospital Assiut Egypt 12222

    Sponsors and Collaborators

    • Amira M elSonbaty

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira M elSonbaty, Amira Elsonbaty, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05853003
    Other Study ID Numbers:
    • bending
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Optic Nerve Diseases

    Study Results

    No Results Posted as of May 10, 2023