Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis

NCT05091177 | Unknown DMC

• 1 other identifier: 2021JiNan
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Myasthenia Gravis; Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (2)

• 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.

  1year

• CMV lgG, lgM antibody titer

  Concentrations of cytomegalovirus lgG and lgM antibodies is collected for analysis.

  1year

Study Arms (2)

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

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

Interventions

Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation DIAGNOSTIC_TEST

Use relevant instruments for inspection

the normal group; the patience group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• XiaoYong Liu: lead

Study Sites (1)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis; Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 25, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

CN (1)