NCT05853003

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

February 19, 2023

Last Update Submit

June 30, 2024

Conditions

Optic Neuropathy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university hospital

Asyut, 12222, Egypt

Location

MeSH Terms

Conditions

Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Amira elsonbaty, PHD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Amira Elsonbaty

Study Record Dates

First Submitted

February 19, 2023

First Posted

May 10, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

April 30, 2023

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations

EG(1)