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.
RCT Entities:
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.