Neuromuscular Ultrasonography Assessment of Optic Nerve in Systemic Lupus Eryhematosus

Neuromuscular Ultrasonography Assessment of Optic Nerve in SLE

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

Study Overview

• Status: Completed
• Conditions: Optic Neuropathy

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 Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 12222
    • Assuit University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult SLE patients, who fulfilled Systemic Lupus International Collaborating Clinics classification criteria for SLE (SLICC) and another group of an apparently healthy subjects will be added to the study

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing diameter (in mm2) of optic nerve in SLE patients and compare them to healthy subjects	comparing diameter (in mm2) of optic nerve in SLE patients and compare them to healthy subjects	over 1 year

Collaborators and Investigators

• Sponsor: Amira M elSonbaty
• Investigators: Principal Investigator: Amira elsonbaty, PHD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Optic Nerve Diseases
• Other Study ID Numbers: bending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No