Methylprednisolone, Optic Neuritis, Treatment
Conditions
Keywords
Optic Neuritis, Methylprednisolone, Retrobulbar injection
Brief summary
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
Detailed description
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone. Enrollment: 50. Randomized groups (2) 1. Standard treatment + placebo 2. Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned
Interventions
DRUGMethylprednisolone Acetate 40 MG/ML [Depo-Medrol]
Retrobulbar injection performed by care provider
DRUGPlacebo Comparator: Standard treatment + placebo
Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned.
Intervention model description
Randomized groups (2) 1. Standard treatment + placebo 2. Standard treatment + intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Both genres * Age between 18 and 85 years old. * Optic neuritis diagnosis ( relative afferent pupillary defect, acquired dyschromatopsia, low vision, prechiasmatic campimetric defect) * 1 month after symptoms started * If is a bilateral simultaneous optic neuritis the eye with the worst vision will be included. * if is a bilateral sequential optic neuritis the eye with lees 1 month evolution will be included.
Exclusion criteria
* Visual field better than 20/60 at the beginning of the study. * History of optic neuritis in the eye under study. * History of additional ophthalmological or neurological pathology that has caused visual loss in the eye under study. * History of previous treatment with intravenous methylprednisolone since the onset of symptoms. * History of high myopia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Visual Capacity | Initial visit, 2-week visit, 1-month visit, 3-month visit | Best corrected visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Color vision | Initial visit, 2-week visit, 1-month visit, 3-month visit | Color vision as measured by Ishihara plates |
| Change from Baseline Visual field defect | Initial visit, 2-week visit, 1-month visit, 3-month visit | Visual fields as measured by Goldmann perimetry |
| Change from Baseline Oct pRNFL (microns) | 2-week visit, 3-month visit | Nerve fiber thickness as measured by OCT |
Countries
Mexico
Contacts
Primary ContactJorge Cárdenas-Belaunzarán, MD, MSc
Backup ContactKaren Flores-Guevara, MD
Outcome results
None listed