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

NAION( Non-arteritic Anterior Ischemic Optic Neuropathy) Clinical Trial

— NAION  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02439866
• Other study ID #: 93222
• Status: Recruiting
• Phase: Phase 3
• First received: May 7, 2015
• Last updated: May 8, 2015
• Start date: February 2014

Study information

• Verified date: January 2014
• Source: hahid Beheshti University of Medical Sciences
• Contact: mohammad pakravan
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Drug:
• placebo
gelatinous capsules filled with sugar as placebo
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity using Snellen chart	Snellen chart	until 6 months	Yes
Secondary	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	Yes