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

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02439866

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)	Drug: placebo Drug: Intravenous methylprednisolone Drug: normobaric oxygen with face mask	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: prescription placebo control Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo	Drug: placebo gelatinous capsules filled with sugar as placebo
Active Comparator: prescription 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	Drug: Intravenous methylprednisolone 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
Active Comparator: prescription 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	Drug: normobaric oxygen with face mask 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

Arm

Intervention/Treatment

Placebo Comparator: prescription placebo

control Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo

Drug: placebo

gelatinous capsules filled with sugar as placebo

Active Comparator: prescription 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

Drug: Intravenous methylprednisolone

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

Active Comparator: prescription 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

Drug: normobaric oxygen with face mask

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

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity using Snellen chart [until 6 months]
Snellen chart

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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