High-dose intravenous methylprednisolone in recent traumatic optic neuropathy; a randomized double-masked placebo-controlled clinical trial.
BACKGROUND
To compare the effect of high-dose intravenous corticosteroid therapy with placebo in the treatment of recent traumatic optic neuropathy (TON).


METHODS
In a double-masked placebo-controlled clinical trial, 31 eyes of 31 patients were randomly assigned to two groups. Patients with history of trauma < or =7 days were included. Unconscious patients, eyes with penetrating trauma and candidates for decompression surgery were excluded. The treatment group (16 eyes) received 250 mg methylprednisolone intravenously every 6 h for 3 days, then 1 mg/kg prednisolone orally for 14 days; the placebo group (15 eyes) received 50 ml normal saline intravenously every 6 h for 3 days, then placebo for 14 days. Visual improvement was considered as a decrease of at least 0.4 logMAR in final visual acuity.


RESULTS
Mean final BCVA (best corrected visual acuity) in the treatment group was 1.11+/- 1.14 and the placebo group was 1.78 +/- 1.23. This difference was not significant (P = 0.13). Visual acuity was improved in 68.8% of the treatment group and 53.3% of the placebo group, but the difference was not statistically significant (P = 0.38). The difference between initial and final BCVA in both groups was determined to be statistically significant (P < 0.001 and 0.010 respectively).


CONCLUSIONS
Our study confirms earlier findings that there is no difference in visual acuity improvement between intravenous high-dose corticosteroids and placebo in treatment of recent TNO.
Entezari
Morteza
M
Department of Ophthalmology, Emam Hossein Medical Center, Ophthalmic Research Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran. entmort@hotmail.com
Rajavi
Zhaleh
Z
Sedighi
Neda
N
Daftarian
Narssis
N
Sanagoo
Masoumeh
M
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002648:Child; D004311:Double-Blind Method; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D020221:Optic Nerve Injuries / Q000188:drug therapy* / Q000503:physiopathology; D011239:Prednisolone / Q000008:administration & dosage; D011379:Prognosis; D014792:Visual Acuity; D014949:Wounds, Nonpenetrating / Q000188:drug therapy* / Q000503:physiopathology
D005938:Glucocorticoids; D011239:Prednisolone; D008775:Methylprednisolone