The goal of this study was to evaluate the effect of posterior sub-tenon injection of methyl prednisolone in eyes with non arthritic anterior ischemic optic neuropathy (NAION). The patients were taken from out patient department of Feiz hospital during 2004-2005. 40 patients with NAION were selected and randomly assigned in two groups. The first group received posterior sub-tenon injection of 40 mg methyl prednisolone. In the second group the injection process was performed as a simulated injection. The patients were followed for 8 weeks, complete eye examination including Visual acuity, IOP, and ophthaslmoscopy were performed at the beginning and at 2, 4, 6 and 8 week steps of the follow up. Visual field was plotted at the beginning and after 8 weeks of follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809182833N1
Registration date:2010-05-08, 1389/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-08, 1389/02/18
Registrant information
Name
Hamid Fesharaki
Name of organization / entity
Isfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1445 0016
Email address
h_fesharaki@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellary for research, Isfahan university of medical sciences
Expected recruitment start date
2004-05-23, 1383/03/03
Expected recruitment end date
2005-06-30, 1384/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Posterior subtenon injection of methylprednisolon in nonartheritic anterior ischemic optic neuropathy
Public title
The treatment of nonartheritic anterior ischemic optic neuropathy by subtenon methylprednisolon
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: recent onset of non arthritic anterior ischemic optic neuropathy, history of acute visual loss, optic disc edema, afferent papillary defect, andangiographic picture, no apparent other ocular or systemic disease related to the acute visual loss
Exclusion criteria: presence of IOP of more than 21 mmhg, history of glaucoma, ocular hypertention, abnormal visual field in the sound eye, high ESR, any additional intervention during the study.
Age
From 37 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Eye Research Center, Isfahan University of medical sciences
Street address
Modarres st. Qods sq.
City
Isfahan
Postal code
8149644874
Approval date
empty
Ethics committee reference number
83154
Health conditions studied
1
Description of health condition studied
Non artritic anterior ischemic opthic neropathy
ICD-10 code
H47.0
ICD-10 code description
Ischaemic optic neuropathy
Primary outcomes
1
Description
Visual acuity
Timepoint
before the intervention and at 2 weeks, 4 weeks, 6 weeks, and 8 weeks steps of follow up after the intervention
Method of measurement
Snellen chart
2
Description
optic disc edema
Timepoint
before the intervention and at 2 weeks, 4 weeks, 6 weeks, and 8 weeks steps of follow up after the intervention
Method of measurement
Slit lamp ophthalmoscopy
Secondary outcomes
1
Description
Plotting the visual field
Timepoint
before the intervention and at 8 weeks steps of follow up after the intervention
Method of measurement
Humphry Automated perimeter
Intervention groups
1
Description
single sub-tenon injection of 40 mg methyle prednisolone
Category
Treatment - Drugs
2
Description
Simulated injection as placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Eye Research Center
Full name of responsible person
Hamid Fesharaki
Street address
Feiz Hospital, Modarres st., Qods sq.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vise chanceller for research, Isfahan University of medical sciences
Full name of responsible person
Hamid Fesharaki MD
Street address
Eye research center, Feiz hospital, Isfahan University of medical sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vise chanceller for research, Isfahan University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan Eye Research Center
Full name of responsible person
Hamid Fesharaki
Position
Assistant professor of ophthalmology
Other areas of specialty/work
Street address
modarrea st. Qods sq
City
Isfahan
Postal code
8149644874
Phone
+98 31 1445 2033
Fax
Email
h_fesharaki@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan Eye Research Center
Full name of responsible person
Hamid Fesharaki
Position
Assistant professor of ophthalmology
Other areas of specialty/work
Street address
Modarres st. Qods sq.
City
Esfahan
Postal code
Phone
+98 31 1445 2033
Fax
Email
h_fesharaki@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Hamid Fesharaki MD
Position
Associate professor, head of the eye department
Other areas of specialty/work
Street address
Eye department ّFeiz hospital, Ghods square
City
Isfahan
Postal code
Phone
+98 31 1445 0016
Fax
+98 31 1445 0016
Email
h_fesharaki@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)