Overview
Outcomes of Steroid and Oxygen Therapy Versus Placebo Therapy in Non-arteritic Anterior Ischemic Optic Neuropathy
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shahid Beheshti University of Medical SciencesTreatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
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