An observational study in Optic Neuritis, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Chinese PLA General Hospital · Observational
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;
88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 150 across 25 observational studies indexed under Optic Neuritis.
Browse Optic Neuritis studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Optic neuritis patients with complete medical records in multicenter from China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Aquaporin 4 antibody seropositive optic neuritis patients, Myelin oligodendrocyte glycoprotein antibody seropositive optic neuritis patients, and double antibodies seronegative optic neuritis patients
Other: observation
different serum antibodies status
Visual Acuity
Last visual acuity records in the hospital
Time frame: At least 1 year from the attack to the final visit
Annual Relapse Rate
Calculated annual relapse rate of different subgroups in the cohort
Time frame: At least 1 year from the attack to the final visit
Epidemiologic characteristics of optic neuritis
Gender, age of first attack, location
Time frame: At least 1 year from the attack to the final visit
Clinical characteristics of optic neuritis
Visual acuity at nadir, pain, optic disc edema
Time frame: At least 1 year from the attack to the final visit
Optical Coherence Tomography
RNFL, macular thickness and GCIPL at different time points
Time frame: At least 1 year from the attack to the final visit
Orbit or Brain MRI at the attack
Lesions of the optic nerve
Time frame: At least 1 year from the attack to the final visit
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
Ran from May 2020 to primary completion in Dec 2020, 7 months.
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This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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