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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial

Conditions
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NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

Intervention / Treatment
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* Drug: placebo
* Drug: Intravenous methylprednisolone
* Drug: normobaric oxygen with face mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: prescription placebo<br>control Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo | Drug: placebo<br>* gelatinous capsules filled with sugar as placebo<br>|
| Active Comparator: prescription Intravenous methylprednisolone<br>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 | Drug: Intravenous methylprednisolone<br>* Intravenous 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 (Prednisolone Fort; Sina Daroo, Iran<br>|
| Active Comparator: prescription normobaric oxygen with face mask<br>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 | Drug: normobaric oxygen with face mask<br>* normobaric oxygen100% with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity using Snellen chart | Snellen chart | until 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual field mean deviation index using the Humphrey Visual Field Analyzer | the Humphrey Visual Field Analyzer (HFA; model 750; Carl Zeiss Meditec, Inc., Dublin, California, USA) | until 6 months |