Optic NeuropathyNCT05853003
Neuromuscular Ultrasonography Assessment of Optic Nerve in Systemic Lupus Eryhematosus
An observational study of Optic Neuropathy, run by Amira M elSonbaty at 1 site in Egypt.
Trial summary
assessing the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optic Neuropathy
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Ultrasonography Assessment of Optic Nerve in SLE
assessing the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.
Read the 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
- Conditions
- Optic Neuropathy
- Medical subject headings
- Optic Nerve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amira M elSonbaty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira M elSonbaty, Assiut University
- Investigators
- Amira elsonbaty, PHD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853003
- Sponsor's protocol ID
- bending
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Ultrasonography Assessment of Optic Nerve in SLE
- ClinicalTrials.gov ID
- NCT05853003
- Acronym / sponsor ID
- bending
- Conditions
- Optic Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Amira M elSonbatyUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
assessing the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Any patient with optic neuritis due to causes other than lupus was excluded from the study: ex.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparing diameter (in mm2) of optic nerve in SLE patients and compare them to healthy subjects
Time frame: over 1 year
comparing diameter (in mm2) of optic nerve in SLE patients and compare them to healthy subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira elsonbaty, PHD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Neuropathy, run by Amira M elSonbaty at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing diameter (in mm2) of optic nerve in SLE patients and compare them to healthy subjects (time frame: over 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.