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

S

Shahid Beheshti University of Medical Sciences

Status and phase

Unknown
Phase 3

Conditions

NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

Treatments

Drug: Intravenous methylprednisolone
Drug: normobaric oxygen with face mask
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02439866
93222

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No 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

Trial design

90 participants in 3 patient groups, including a placebo group

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

Trial contacts and locations

0

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Central trial contact

mohammad pakravan

Data sourced from clinicaltrials.gov

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