Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION

Sponsor

Second Military Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02329288

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it.

Intravenous injection of glucocorticoid have proven to be effective in treatment of Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.

Condition or Disease	Intervention/Treatment	Phase
Triamcinolone Acetonide Optic Neuropathy, Ischemic	Drug: Triamcinolone Acetonide Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Triamcinolone Acetonide 40mg/1ml	Drug: Triamcinolone Acetonide
Placebo Comparator: placebo 1ml	Drug: placebo

Arm

Intervention/Treatment

Active Comparator: Triamcinolone Acetonide

40mg/1ml

Drug: Triamcinolone Acetonide

Placebo Comparator: placebo

1ml

Drug: placebo

Outcome Measures

Primary Outcome Measures

Changes of Best corrected visual acuity(BCVA) [baseline and 1month, 3month]

Secondary Outcome Measures

Changes of Visual Field [baseline and 1month, 3month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days)

Exclusion Criteria:

Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy) Neurologic defect Abnormal ESR, CRP, any history of retina or vitreal surgery Severe corneal opacity which makes retina examination impossible