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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05853003
Other study ID # bending
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date April 30, 2023

Study information

Verified date July 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date April 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Assuit university hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Amira M elSonbaty

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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