High-dose intravenous methylprednisolone in recent traumatic optic neuropathy; a randomized double-masked placebo-controlled clinical trial

• Published in: Graefe's archive for clinical and experimental ophthalmology Vol. 245; no. 9; pp. 1267 - 1271
• Main Authors: Entezari, Morteza, Rajavi, Zhaleh, Sedighi, Neda, Daftarian, Narssis, Sanagoo, Masoumeh
• Format: Journal Article
• Language: English
• Published: Germany Springer Nature B.V 01.09.2007
• Subjects: Administration, Oral; Adolescent; Adult; Child; Double-Blind Method; Glucocorticoids - administration & dosage; Humans; Infusions, Intravenous; Male; Methylprednisolone - administration & dosage; Middle Aged; Ophthalmology; Optic Nerve Injuries - drug therapy; Optic Nerve Injuries - physiopathology; Prednisolone - administration & dosage; Prognosis; Visual Acuity; Wounds, Nonpenetrating - drug therapy; Wounds, Nonpenetrating - physiopathology
• ISSN: 0721-832X; 1435-702X
• DOI: 10.1007/s00417-006-0441-0

To compare the effect of high-dose intravenous corticosteroid therapy with placebo in the treatment of recent traumatic optic neuropathy (TON). 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. 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). 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.