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

Phase 3

• Conditions: NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)
• Interventions: Drug: placebo; Drug: Intravenous methylprednisolone; Drug: normobaric oxygen with face mask

• Registration Number: NCT02439866
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-02
• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-08
• Last Update Submitted: 2015-05-08
• Study First Posted: 2015-05-12
• Last Update Posted: 2015-05-12
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with recent onset ( within 2 weeks) of non-arteritic ischemic optic neuropathy

Exclusion Criteria

• the presence of glaucoma, or any other ocular, neurologic, or systemic disease that may influence visual acuity and visual field; abnormal results in laboratory assessments, including an abnormally elevated erythrocyte sedimentation rate and positive serum C-reactive protein;
• a history of previous ocular surgery;
• a history of prior treatment of any type for NAION;
• systemic condition such as diabetes mellitus and poorly controlled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prescription placebo	placebo	control Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo
prescription Intravenous methylprednisolone	Intravenous methylprednisolone	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
prescription normobaric oxygen with face mask	normobaric oxygen with face mask	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

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity using Snellen chart	until 6 months	Snellen chart

Secondary Outcome Measures

Name	Time	Method
Visual field mean deviation index using the Humphrey Visual Field Analyzer	until 6 months	the Humphrey Visual Field Analyzer (HFA; model 750; Carl Zeiss Meditec, Inc., Dublin, California, USA)