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Comparison of effect of intavitreal injection of erythropoeitin with intravenous erythropoeitin on visual function of patients with non-arteritic anterior ischemic optic neuropathy with control group

Protocol summary

Summary
Objective: to compare effect of intravitreal and intravenous injection of erythropoeitin on visual function of patients with non-arteritic anterior ischemic optic neuropathy with control group Design: randomized, blinded, single center clinical trial Participants : inclusion criteria : patients with non-arteritic anterior ischemic optic neuropathy with decreased vision, optic disc swelling, compatible visual field defects; normal ESR and CRP; lack of signs and sypmtoms suggesting giant cell arteritis(headache, jaw claudication); normal Na, Mg, K, liver function tests, Hgb; refered within 2 weeks after onset of decreased vision. Excluson criteria: high ESR and CRP; signs and sypmtoms suggesting giant cell arteritis; abnormal Na, Mg, K, liver function tests, Hgb; refered after 2 weeks of decreased vision; current smoking habbit Sample size : 150 patients ( 50 patients for each group) Conduct and interventions : patients will bw asignned randomly to 3 groups : group1 will be observed. Group 2 will have intravitreal injection of erythropoeitin; and group 3 will be undergone intravenous injection of erythropoeitin Main outcome measures : visual acuity; visual field; retinal nerve fiber layer thickness

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102275914N2
Registration date: 2011-03-05, 1389/12/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-03-05, 1389/12/14
Registrant information
Name
Shima Hatamkhnai
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 5548
Email address
hatamkhani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Eye research center, Rasoul Akram Hospital, Tehran University of Medical Sciences
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2012-02-29, 1390/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of intavitreal injection of erythropoeitin with intravenous erythropoeitin on visual function of patients with non-arteritic anterior ischemic optic neuropathy with control group
Public title
Effect of erythropoeitin on visual function of patients with non-arteritic anterior ischemic optic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients with non-arteritic anterior ischemic optic neuropathy with decreased vision, optic disc swelling, compatible visual field defects; normal ESR and CRP; lack of signs and sypmtoms suggesting giant cell arteritis(headache, jaw claudication); normal Na, Mg, K, liver function tests, Hgb; refered within 2 weeks after onset of decreased vision. Excluson criteria: high ESR and CRP; signs and sypmtoms suggesting giant cell arteritis; abnormal Na, Mg, K, liver function tests, Hgb; refered after 2 weeks of decreased vision; current smoking habbit
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
8th Floor, Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave.
City
Tehran
Postal code
Approval date
2010-11-22, 1389/09/01
Ethics committee reference number
134

Health conditions studied

1

Description of health condition studied
ischemic optic neuropathy
ICD-10 code
H47.0
ICD-10 code description
Disorders of optic nerve, not elsewhere classified

Primary outcomes

1

Description
Visual acuity
Timepoint
first and 7th day, 1st and 3rd and 6th month
Method of measurement
ُSellen chart and convertion to logMAR

Secondary outcomes

1

Description
Visual field
Timepoint
1st and 7th day, 1st and 3rd and 6th month
Method of measurement
Humphery perimetry, SITA standard 24-2 strategy

2

Description
Retinal nerve fiber layer thickness
Timepoint
1st day and 1st,3rd,6th ,
Method of measurement
Optical coherence tomogram(OCT)

Intervention groups

1

Description
Group3: Admitting the patient. 1st day : Slow intravenous infusion of 20000 units of erythropoeitin with controlling vital signs every 15minutes during infusion; recording visual acuity 2nd day : as above 3rd day : as above
Category
Treatment - Drugs

2

Description
Group 2 : Intra vitreal injection of 2000 units of erythropoeitin in 0.2cc with 29 gauge needle under sterile condition in operating room, 4 mm from limbus in phakic and 3 mm from limbus in aphakic or pseudophakic patients
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
Dr. Reza Soudi
Street address
8th Floor, Ophthalmology clinics and emergency ward, Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of medical sciences
Full name of responsible person
Dr. Mehdi Modarreszade
Street address
8th Floor, Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Tehran University ofMedical Sciences
Full name of responsible person
Reza Soudi
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Ophthalmology Ward, Rasoul Akram hospital, Niayesh St., Sattarkhan Ave.
City
Tehran
Postal code
Phone
+98 21 4441 5677
Fax
Email
rezasoudi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Eye research center, Rasoul akram hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Modarreszade
Position
Professor of Ophthalmology
Other areas of specialty/work
Street address
8th Floor, Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave.
City
Tehran
Postal code
Phone
+98 21 6655 8811
Fax
Email
mmodarres51@yahoo.com
Web page address
http://www.iraneyeresearch.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Hatamkhani
Position
Pharmacotherapy Resident
Other areas of specialty/work
Street address
8th Floor, Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave.
City
Tehran
Postal code
Phone
+98 21 6665 5881
Fax
Email
hatamkhani@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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