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

The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02439866

Acronym

NAION

Enrollment

Registered

2015-05-12

Start date

2014-02-28

Completion date

Unknown

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

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.

Interventions

DRUGplacebo

gelatinous capsules filled with sugar as placebo

DRUGIntravenous 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

DRUGnormobaric 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Best corrected visual acuity using Snellen chart	until 6 months	Snellen chart

Secondary

Measure	Time frame	Description
Visual field mean deviation index using the Humphrey Visual Field Analyzer	until 6 months	the Humphrey Visual Field Analyzer (HFA; model 750; Carl Zeiss Meditec, Inc., Dublin, California, USA)

Countries

Iran

Contacts

Primary Contactmohammad pakravan

labbafi@hotmail.com009822591616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026