drugset / Trial / NCT02439866

Outcomes of Steroid and Oxygen Therapy Versus Placebo Therapy in Non-arteritic Anterior Ischemic Optic Neuropathy

NCT02439866

RandomizedParallel-groupSingle-blindTreatment

Summary

Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity was the main outcome measure, and mean deviation index of visual field test and peripapillary retinal nerve fiber layer thickness were secondary outcome measures.

Timeline

Start
2014-02
Primary completion
2015-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 500 mg Intravenous
Comparator Oxygen Other / unclassified 100 % Other
Comparator Prednisolone Other / unclassified 1 mg/kg Oral