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Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis

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ClinicalTrials.gov Identifier: NCT05091177
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
XiaoYong Liu, First Affiliated Hospital of Jinan University

Brief 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. 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.

Condition or disease Intervention/treatment
Ocular Myasthenia Gravis Cytomegalovirus Infections Diagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort Intervention/treatment
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.
Diagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation
Use relevant instruments for inspection

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.
Diagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation
Use relevant instruments for inspection




Primary Outcome Measures :
  1. 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.

  2. CMV lgG, lgM antibody titer [ Time Frame: 1year ]
    Concentrations of cytomegalovirus lgG and lgM antibodies is collected for analysis.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05091177


Locations
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China, Guangdong
The First Affiliated Hospital of Jinan University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: qing Zhou    18928903759    kerryzh@163.com   
Sponsors and Collaborators
XiaoYong Liu
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Responsible Party: XiaoYong Liu, Deputy chief physician, First Affiliated Hospital of Jinan University
ClinicalTrials.gov Identifier: NCT05091177    
Other Study ID Numbers: 2021JiNan
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Acetylcholine
Antibodies
Neostigmine
Immunologic Factors
Physiological Effects of Drugs
Cholinesterase Inhibitors