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

Primary Purpose

NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
placebo
Intravenous methylprednisolone
normobaric oxygen with face mask
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

prescription placebo

prescription Intravenous methylprednisolone

prescription normobaric oxygen with face mask

Arm Description

control Group 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

Outcomes

Primary Outcome Measures

Best corrected visual acuity using Snellen chart
Snellen chart

Secondary Outcome Measures

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)

Full Information

First Posted
May 7, 2015
Last Updated
May 8, 2015
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02439866
Brief Title
Outcomes of Steroid and Oxygen Therapy Versus Placebo Therapy in Non-arteritic Anterior Ischemic Optic Neuropathy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prescription placebo
Arm Type
Placebo Comparator
Arm Description
control Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo
Arm Title
prescription Intravenous methylprednisolone
Arm Type
Active Comparator
Arm 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
Arm Title
prescription normobaric oxygen with face mask
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
gelatinous capsules filled with sugar as placebo
Intervention Type
Drug
Intervention Name(s)
Intravenous methylprednisolone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
normobaric oxygen with face mask
Intervention Description
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
Primary Outcome Measure Information:
Title
Best corrected visual acuity using Snellen chart
Description
Snellen chart
Time Frame
until 6 months
Secondary Outcome Measure Information:
Title
Visual field mean deviation index using the Humphrey Visual Field Analyzer
Description
the Humphrey Visual Field Analyzer (HFA; model 750; Carl Zeiss Meditec, Inc., Dublin, California, USA)
Time Frame
until 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammad pakravan
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
City
Tahran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohammad pakravan
Phone
009822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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