Ocular Myasthenia GravisNCT05091177
Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis
An observational study of Ocular Myasthenia Gravis and Cytomegalovirus Infections, run by XiaoYong Liu at 1 site in China.
Trial summary
Ocular myasthenia gravis (OMG) is an autoimmune neuromuscular disease mediated by pathogenic autoantibodies. Its etiology and pathogenesis are not completely clear. The occurrence and development of OMG are the result of the joint participation of genetic factors, environmental factors and immune factors. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Myasthenia Gravis, Cytomegalovirus Infections
- What is being tested?
- Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2021
- How long will I take part?
- 1 Year
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 75 patients and 40 healthy volunteers are collected who are diagnosed with ocular myasthenia gravis in the First Affiliated Hospital of Jinan University from January 2019 to January 2022
the patience group Inclusion criteria:
- Clinical manifestations: fluctuating eye muscle weakness;
- Positive ice test, fatigue test, rest and sleep test;
- Positive neostigmine test;
- Serum acetylcholine receptor antibody and other antibodies are positive;
- Repeated electrical nerve stimulation test attenuation is positive;
- Meeting the above diagnostic criteria of the first, or any of the other 4, at the same time excluding other diseases caused by eye palsy can be clear diagnosis. the patience group exclusion criteria:
- General myasthenia gravis;
- History of other eye diseases
- With other autoimmune diseases or other inflammatory diseases;
- Patients with diabetes, hypertension, coronary heart disease and other chronic medical history or cancer diseases;
- Hepatitis B virus, hepatitis C virus, HIV, syphilis positive patients;
- immunosuppressive drugs (such as glucocorticoid, azathioprine and cyclosporine A), gamma globulin for intravenous injection, plasmapheresis, etc., within 3 months before treatment;
- Previous thymic resection or thymus radiation therapy;
- Pregnancy or lactation. the control group Inclusion criteria:
- No obvious abnormality was found in the recent physical examination results;
- No history of autoimmune diseases;
- Have not received antiviral therapy or immunotherapy within 3 months;
- No history of other eye diseases or systemic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
qing Zhou, 18928903759, kerryzh@163.com
About this study
Ocular myasthenia gravis (OMG) is an autoimmune neuromuscular disease mediated by pathogenic autoantibodies. Its etiology and pathogenesis are not completely clear. The occurrence and development of OMG are the result of the joint participation of genetic factors, environmental factors and immune factors. The role of infectious factors in the pathogenesis of autoimmune diseases is a hot topic in the international discussion.By analyzing the difference in the positive rate and titer of CMV antibodies between ocular myasthenia gravis and healthy people. By analyzing the correlation between the positive rate and titer of CMV antibodies and ocular myasthenia gravis clinical manifestations, acetylcholine receptor antibodies, ESR, hypersensitive C-reactive protein, complement C3, complement C4 and thymus status.To investigate the correlation between cytomegalovirus and ocular myasthenia gravis. It can provide new insights for further studies on the etiology and possible pathogenesis of ocular myasthenia gravis.
Read the detailed description
A total of 75 patients and 40 healthy volunteers are collected who are diagnosed with ocular myasthenia gravis in the First Affiliated Hospital of Jinan University from January 2019 to January 2022 . All subjects undergo eye examination and cytomegalovirus antibody detection. OMG patients undergo the following examinations: serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test, chest CT, low frequency repetitive nerve stimulation (orbicularis oculi, levator palpebrae superioris, frontalis muscle), thyroid function and color ultrasound. The difference of lgG positive rate ,lgM positive rate of CMV and antibody titers of lgG and lgM are analyzed between the two groups, and the relationship between CMV antibody and OMG clinical manifestations, acetylcholine receptor antibody, laboratory indicators and thymus status are analyzed.
- Being tested
- Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation
- Medical subject headings
- Myasthenia Gravis, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulationDiagnostic test
Use relevant instruments for inspection
| Study group | Role | What they receive |
|---|---|---|
| the patience group | underwent the following examinations: serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test, chest CT, low frequency repetitive nerve stimulation (orbicularis oculi muscle, levator palpebrae muscle, frontalis muscle), thyroid function and color ultrasound. Receives: Diagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation | |
| the normal group | underwent the following examinations: serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test, chest CT, low frequency repetitive nerve stimulation (orbicularis oculi muscle, levator palpebrae muscle, frontalis muscle), thyroid function and ultrasound. Receives: Diagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV lgG, lgM positive rate
CMV-lgG titer ≥14IU/ mL is positive, 12-14 IU/ mL is critical, and 0-12 IU/ mL is negative. CMV-lgM titer > 22U/ mL is positive, 18-22U/mL is critical, and 0-18U/mL is negative.
Measured: 1year
CMV lgG, lgM antibody titer
Concentrations of cytomegalovirus lgG and lgM antibodies is collected for analysis.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Myasthenia GravisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- XiaoYong Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XiaoYong Liu, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091177
- Sponsor's protocol ID
- 2021JiNan
- Status last verified
- Oct 2021
- First submitted
- 9 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT05091177
- Acronym / sponsor ID
- 2021JiNan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- XiaoYong LiuUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Oct 2021 (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.
Ocular myasthenia gravis (OMG) is an autoimmune neuromuscular disease mediated by pathogenic autoantibodies. Its etiology and pathogenesis are not completely clear. The occurrence and development of OMG are the result of the joint participation of genetic factors, environmental factors and immune factors. The role of infectious factors in the pathogenesis of autoimmune diseases is a hot topic in the international discussion.By analyzing the difference in the positive rate and titer of CMV antibodies between ocular myasthenia gravis and healthy people. By analyzing the correlation between the positive rate and titer of CMV antibodies and ocular myasthenia gravis clinical manifestations, acetylcholine receptor antibodies, ESR, hypersensitive C-reactive protein, complement C3, complement C4 and thymus status.To investigate the correlation between cytomegalovirus and ocular myasthenia gravis. It can provide new insights for further studies on the etiology and possible pathogenesis of ocular myasthenia gravis.
Detailed description
A total of 75 patients and 40 healthy volunteers are collected who are diagnosed with ocular myasthenia gravis in the First Affiliated Hospital of Jinan University from January 2019 to January 2022 . All subjects undergo eye examination and cytomegalovirus antibody detection. OMG patients undergo the following examinations: serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test, chest CT, low frequency repetitive nerve stimulation (orbicularis oculi, levator palpebrae superioris, frontalis muscle), thyroid function and color ultrasound. The difference of lgG positive rate ,lgM positive rate of CMV and antibody titers of lgG and lgM are analyzed between the two groups, and the relationship between CMV antibody and OMG clinical manifestations, acetylcholine receptor antibody, laboratory indicators and thymus status are analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the patience group | – | Diagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulationunderwent the following examinations: serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test, chest CT, low frequency repetitive nerve stimulation (orbicularis oculi muscle, levator palpebrae muscle, frontalis muscle), thyroid function and color ultrasound. |
| the normal group | – | Diagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulationunderwent the following examinations: serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test, chest CT, low frequency repetitive nerve stimulation (orbicularis oculi muscle, levator palpebrae muscle, frontalis muscle), thyroid function and ultrasound. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 75 patients and 40 healthy volunteers are collected who are diagnosed with ocular myasthenia gravis in the First Affiliated Hospital of Jinan University from January 2019 to January 2022
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulationUse relevant instruments for inspection | Diagnostic test | the normal group, the patience group |
Primary outcome
CMV lgG, lgM positive rate
Time frame: 1year
CMV-lgG titer ≥14IU/ mL is positive, 12-14 IU/ mL is critical, and 0-12 IU/ mL is negative. CMV-lgM titer > 22U/ mL is positive, 18-22U/mL is critical, and 0-18U/mL is negative.
CMV lgG, lgM antibody titer
Time frame: 1year
Concentrations of cytomegalovirus lgG and lgM antibodies is collected for analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Ocular Myasthenia Gravis and Cytomegalovirus Infections, run by XiaoYong Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 25 Oct 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV lgG, lgM positive rate (time frame: 1year). The study lists 2 primary outcomes in all. 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 25 Oct 2021.