The study of Optical coherence tomography and Optical coherence tomography angiography of the patients with Non-Arteritic Anterior Ischemic Optic Neuropathy before and after receiving Citicoline
Determination of the effect of Citicoline on OCTA and OCT in patients with anterior non-arterial optic nerve neuropathy (NAION)
Design
Patients are selected as case series. Approximately 20 patients are selected and given medication.
Settings and conduct
The leading study will be a prospective study which will be conducted in 1402 at the ophthalmology clinic of Khalili Hospital in Shiraz. This is a pre- and post-clinical trial study. The study population are patients with anterior optic nerve neuropathy based on inclusion criteria. In this group, citicoline ampule with a dose of 500 mg is injected intramuscularly once a week for 3 weeks. Patients undergo paraclinical examinations in the first week of AION attack and one month after starting treatment.
Participants/Inclusion and exclusion criteria
The patient is in the first week of the attack.
2. Age: Older than 18 years
3. Not taking Citicoline drug in the past three months, as well as antioxidants and multivitamins and having a special diet
4. Failure to receive previous treatment
5. Absence of congenital and acquired retinal diseases
6. Absence of ocular pathology such as glaucoma, retinal disease and uveitis
7. No corticosteroid drugs
8. Lack of Levodopa
Intervention groups
For the experimental group, the drug is prescribed. In this group, citicoline ampule with a dose of 500 mg is injected intramuscularly once a week for 3 weeks. Patients will undergo paraclinical examinations during the first week of AION attack and one month after starting treatment.
Main outcome variables
the thickness of the ganglion cell layer; the thickness of the optic nerve fiber layer; SVC thickness in OCTA; SVC thickness in OCTA; retinal thickness in OCTA; Choroidal thickness in OCTA
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240107060637N1
Registration date:2024-01-28, 1402/11/08
Registration timing:retrospective
Last update:2024-01-28, 1402/11/08
Update count:0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Mohammad reza Khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2830
Email address
khalilimr57@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-01-13, 1402/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of Optical coherence tomography and Optical coherence tomography angiography of the patients with Non-Arteritic Anterior Ischemic Optic Neuropathy before and after receiving Citicoline
Public title
the effect of Citicoline on the retina in Non-Arteritic Anterior Ischemic Optic Neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is in the first week of the attack
Age: Older than 18 years
Exclusion criteria:
Consumption of Citicoline in the last three months as well as antioxidants and multivitamins and having a special diet
Receiving previous treatment
Congenital and acquired retinal diseases
Presence of ocular pathology such as glaucoma, retinal disease and uveitis
Taking corticosteroid drugs
Taking Levodopa
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-01-03, 1402/10/13
Ethics committee reference number
IR.SUMS.MED.REC.1402.468
Health conditions studied
1
Description of health condition studied
Non-Arteritic Anterior Ischemic Optic Neuropathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of damage in the thickness of the ganglion cell layer and optic nerve fiber layer is reduced in OCT images of the patient before and after receiving citicoline.2. Vascular density in OCTA should not be reduced.
Timepoint
Patients will undergo paraclinical examinations during the first week of AION attack and one month after the start of treatment
Method of measurement
Optical coherence tomography and Optical coherence tomography angiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, Citicoline ampule with a dose of 500 mg is injected intramuscularly once a week for 3 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Dr Mohammadreza Khalili
Street address
Khalilii St, Mollasadra St
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3627 1382
Email
khalili@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammadhashem Hashempour
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Province
Fars
Postal code
7134853185
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad reza Khalili
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Zand St., Stad block, in front of the Medical School, Poostachi Ophthalmology Research Center
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3230 2830
Fax
Email
khalilimr57@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad reza Khalili
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Zand St., Stad block, in front of the Medical School, Poostachi Ophthalmology Research Center
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3230 2830
Fax
Email
khalilimr57@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad reza Khalili
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Zand St., Stad block, in front of the Medical School, Poostachi Ophthalmology Research Center
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3230 2830
Fax
Email
khalilimr57@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome is shared after making people unidentifiable.
When the data will become available and for how long
Starting the access period from the date of publication of the results up to 5 years later
To whom data/document is available
Researchers and people working in the pharmaceutical industry
Under which criteria data/document could be used
Those who intend to produce, prescribe and research this drug
From where data/document is obtainable
khalilimr57@gmail.com
Dr Mohammadreza Khalili
What processes are involved for a request to access data/document
Examination and receiving of medication by patients for one month
Collecting OCTA and OCT photos for one month.