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

NCT02439866 | Unknown Phase 3

• 1 other identifier: 93222
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity using Snellen chart

  Snellen chart

  until 6 months

Secondary Outcomes (1)

• Visual field mean deviation index using the Humphrey Visual Field Analyzer

  until 6 months

Study Arms (3)

prescription placebo

PLACEBO COMPARATOR

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

Drug: placebo

prescription Intravenous methylprednisolone

ACTIVE COMPARATOR

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

prescription normobaric oxygen with face mask

ACTIVE COMPARATOR

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

Interventions

placebo DRUG

gelatinous capsules filled with sugar as placebo

prescription placebo

Intravenous methylprednisolone DRUG

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

prescription Intravenous methylprednisolone

normobaric oxygen with face mask DRUG

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

prescription normobaric oxygen with face mask

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Unknown Facility

Tehran, Iran

RECRUITING

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

mohammad pakravan

CONTACT

009822591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shahid Beheshti Medical University

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: February 1, 2014
• Primary Completion: July 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2014-01

Locations

IR (1)