Optic Neuritis Recovery After Oral or IV Corticosteroids
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- corticosteroids
Compared with
- corticosteroids
What it measured
Main measures
P100 latency of the Visual Evoked Potential in the affected eye
6 months
Myelin repair
Other measures (3)
High contrast visual acuity
one and six months
Visioncontrast sensitivity
one and six months
P100 latency of the Visual Evoked Potential in the affected eye
one month
Myelin repair
Who could take part
Optic neuritis · 18 to 64
Inclusion Criteria: 1. Males/Females who are ≥ 18 years old and \< 65 years old and are capable of understanding and complying with the protocol 2. Have a diagnosis of unilateral acute demyelinating optic neuritis and will be treated with high dose corticosteroids 3. Are within 14 days of symptom onset 4. Have a visual acuity in the affected of eye of ≥ 20/40 5. Have not received corticosteroids in the last thirty (30) days 6. Medications that could potentially affect the VEP P100 amplitude or may cause drowsiness/difficulty with visual fixation are allowed if there has been no change in dose within 30 days of study enrollment or anytime during the study. These medications include: 1. Carbamazepine or other anticonvulsants (45) 2. Benzodiazepines 3. Opioid and opiates 4. Barbiturates 5. Sleep aids such as zopiclone or trazadone 6. Tricyclic antidepressants 7. Have given written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care Exclusion Criteria: 1. Have another medical condition that could affect the visual outcomes, such as, but not limited to, diabetes retinopathy, glaucoma, cataracts and optic neuropathy not due to a demyelinating lesion 2. Have had optic neuritis in the same eye previously
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Patients aged 18-65 with acute demyelinating optic neuritis where treatment with high dose corticosteroids are already been chosen by the patient and the diagnosing physician will be contacted for screening and enrollment. Patients will then be randomized to receive equivalent doses of either intravenous (IV) or oral corticosteroid treatment. Optic nerve function assessments will be compared at baseline, prior to treatment, one and six months post corticosteroid treatment. This will allow for a comparison on whether the route of medication plays a role in the effectiveness of treatment with high dose corticosteroids.
Papers
Loading reviews and guidelines…
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History
Started
Mar 2012
Main results due
May 2015
Finished
May 2015
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