Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University Health Science Center | OTHER |
Not provided
Not provided
Not provided
Not provided
This will be a hospital-based retrospective multi-center study on epidemiologic and clinical characteristics of optic neuritis among Chinese. The investigation will cover about 29 provinces or municipalities all around China.
This national investigation will be conducted to describe the epidemiology and clinical characteristics of optic neuritis in China. All the patients will be divided into 3 groups according to the serum demyelinating antibodies (Aquaporin-4 antibody seropositive group, Myelin oligodendrocyte glycoprotein antibody seropositive group and double seronegative group). The investigator will analyze the differences among the three groups.
Primary outcomes:
To dig out the different visual acuity (VA, LogMAR) prognosis among the three groups;
Secondary outcomes:
Other epidemiological and clinical characteristics of optic neuritis patients will be analyzed among the three groups;
Orbital or Brain MRI is required in this study, which could avoid the misdiagnosis. We will collect and analyze these MRI data too (including the optic nerve lesions in T2 weight images and T1 enhanced MRI);
Results of optical coherence tomography (OCT) (including peripapillary retinal nerve fiber layer, macular thickness ,and ganglion cell and inner plexiform layer complex) at different time point are also needed in this study. However, OCT is not necessarily required;
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| optic neuritis | Aquaporin 4 antibody seropositive optic neuritis patients, Myelin oligodendrocyte glycoprotein antibody seropositive optic neuritis patients, and double antibodies seronegative optic neuritis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation | Other | different serum antibodies status |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Last visual acuity records in the hospital | At least 1 year from the attack to the final visit |
| Annual Relapse Rate | Calculated annual relapse rate of different subgroups in the cohort | At least 1 year from the attack to the final visit |
| Measure | Description | Time Frame |
|---|---|---|
| Epidemiologic characteristics of optic neuritis | Gender, age of first attack, location | At least 1 year from the attack to the final visit |
| Clinical characteristics of optic neuritis | Visual acuity at nadir, pain, optic disc edema |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Optic neuritis patients with complete medical records in multicenter from China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mo Yang, Ph.D | Contact | +86-010-66938375 | doctoryangmo@icloud.com | |
| Mengying Lai, M.D | Contact | +86-010-66938175 | 78313749@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Shihui Wei, M.D | Ophthalmology, the Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100835 | China |
It is a multi center study of optic neuritis, the individual participant data belongs to every single center. Now, we are applying for the approval. However, the details will not be available until all the centers approved.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009902 | Optic Neuritis |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
| At least 1 year from the attack to the final visit |
| Optical Coherence Tomography | RNFL, macular thickness and GCIPL at different time points | At least 1 year from the attack to the final visit |
| Orbit or Brain MRI at the attack | Lesions of the optic nerve | At least 1 year from the attack to the final visit |