Determining the neuroprotective effect of Brimonidine and placebo on visual indicators in optic neuritis patients
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 3 on 60 patients, R statistical software was used for randomization.
Settings and conduct
After understanding the patients and obtaining a written consent, the patients are voluntarily directed to the Optometry Department of Zahra Zahedan Ophthalmology Hospital, where the best corrected visual acuity of both eyes, contrast sensitivity, and color vision are taken.
Also, in order to conduct the study in a blinded manner and to prevent bias from the patients, brimonidine drops and placebo will be used in the patients in the same and similar appearance and with certain coding.
The studied patients were divided into two groups receiving brimonidine and not receiving brimonidine, in the group of patients they will receive 0.2% brimonidine eye drops for 3 months. All patients in both groups, one month and 3 months later, will perform all visual indicators again in the described way.
Participants/Inclusion and exclusion criteria
All patients with acute optic neuritis referred to Zahedan alzahra Ophthalmology Hospital from the age of 18 to 45 years who do not have a previous neurological history and drugs that weaken the immune system.
Intervention groups
Intervention group for whom brimonidine drops and routine measures are prescribed.
control group for whom routine measures are prescribed.
Main outcome variables
Visual acuity; Visual contrast; Color vision
General information
Reason for update
Acronym
ENEB
IRCT registration information
IRCT registration number:IRCT20221127056631N1
Registration date:2022-12-03, 1401/09/12
Registration timing:registered_while_recruiting
Last update:2022-12-03, 1401/09/12
Update count:0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
mahdi asani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3230 3035
Email address
dr.mahdiasani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the neuroprotective effect of Brimonidine and placebo on visual indices in optic neuritis patients
Public title
Evaluation of neuroprotective effect of Brimonidine on visual indices in optic neuritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and free consent to participate in the study
Acute optic neuritis
The age range of patients is 18 to 45 years
Spherical equivalent refractive error of three diopters of myopia to one and a half diopters of hyperopia
Exclusion criteria:
History of optic neuritis in another normal eye
Use or history of using drugs affecting the immune system
History of any type of retinal surgery
History of optic disc swelling in each eye
Having amblyopia in one or both eyes
Glaucoma
Diabetic retinopathy or any type of maculopathy
Color blindness
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of patients to two groups is done by the permutation block stratified randomization method. First, eligible referring patients are classified according to age and gender in the order of arrival. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinding method is used in this research. So that the patient will not be aware of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan University of Medical Sciences
Street address
Medical Sciences Campus., Dr. Hasabi Square., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813637461
Approval date
2022-04-10, 1401/01/21
Ethics committee reference number
IR.ZAUMS.REC.1401.099
Health conditions studied
1
Description of health condition studied
Optic neuritis
ICD-10 code
H46
ICD-10 code description
Optic neuritis
Primary outcomes
1
Description
Visual acuity
Timepoint
Measurement on the first day and one month later and three months later
Method of measurement
Visual acuity measured by Snellen's chart.
2
Description
Contrast sensivity
Timepoint
Measurement on the first day and one month later and three months later.
Method of measurement
Contrast sensitivity measured by Young's chart.
3
Description
Color vision
Timepoint
Measurement on the first day and one month later and three months later
Method of measurement
Color vision as measured by the Ishihara chart.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine interventions and brimonidine drops 0.2%
Category
Treatment - Drugs
2
Description
Control group: Routine interventions and artificial tear placebo drops
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Alzahra Eye Hospital
Full name of responsible person
Mahdi Asani
Street address
Motahari Blvd., Zhedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813637461
Phone
+98 17 3268 1659
Email
alzahra.eye@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahedan University of Medical Scinsces
Street address
Campus of Zahedan University of Medical Sciences
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 17 3445 6555
Email
zaums@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
5
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
Zahedan University of Medical Sciences
Full name of responsible person
Mahdi Asani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahari Blvd., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813637461
Phone
+98 17 3243 4564
Email
Dr.Mahdiasani@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Arish
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Motahari Blvd., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813637461
Phone
+98 17 3346 5676
Email
Dr.mohahadarish@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahdi Asani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahari Blvd., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813637461
Phone
+98 17 3244 6544
Email
Dr.mahdiasani@yahoo.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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data
When the data will become available and for how long
All time
To whom data/document is available
All person
Under which criteria data/document could be used
To improve the treatment and research process
From where data/document is obtainable
Contact my personal email at Dr.mahdiasani@yahoo.com or phone number 00989117721785 in the name of Dr. Asani so that the information can be sent to them as a file.
What processes are involved for a request to access data/document
Information will be sent about ten days after the email