Assessment of efficacy of brimonidine versus latanoprost in normal tension glaucoma
Design
Clinical trials with a control group, non - blindness, randomized in Permuted block method with 100 patients
Settings and conduct
The current study is a single centered Single-blinded clinical trial that will occur at Alzahra Hospital in Zahedan. Patients will be divided into two intervention groups according to randomized permuted block method. In this study patients are randomly divided into intervention groups after signing informed consent unawarely.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients referring to Ophthalmology Clinic, who will be diagnosed with Normal Tension Glaucoma, based on findings such as: normal Intraocular pressure, Optic nerve changes, and visual field changes
Exclusion criteria:
patients on treatment
patients with drug allergy
eye surgery
past ophthalmologic diseases history
Intervention groups
Intervention group1: Prescription of eyedrop Brimonidine 0.2% made in Iranian Sina daroo inc, every 12 hours in the eye
Intervention group 2: Prescription of Eyedrop latanoprost 0.005% made in Iranian Sina daroo inc. once daily at 9 PM in the eye
Main outcome variables
Laminar and prelaminar thickness of lamina cribrosa
IOP (intraocular pressure)
visual field defect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120817010617N7
Registration date:2021-05-20, 1400/02/30
Registration timing:registered_while_recruiting
Last update:2021-05-20, 1400/02/30
Update count:0
Registration date
2021-05-20, 1400/02/30
Registrant information
Name
morteza Sedaghat Kia
Name of organization / entity
zaums
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 9540
Email address
morimedico@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of efficacy of brimonidine versus latanoprost for visual improvement in normal tension glaucoma patients
Public title
Efficacy of brimonidine & latanoprost in treatment normal tension glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referring to Alzahra Ophthalmology Clinic, Who will be diagnosed with Normal Tension Glaucoma
Exclusion criteria:
patients on treatment
patients with drug allergy
eye surgery
past ophthalmologic diseases history
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to intervention group A and B using randomized block design with block size 6. Randomization was done using online random allocation software
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind study, only patients are blinded to the content of drug A or B. The examiner, optometrist and secretary of clinic are completely informed of the contents of type A and B drugs.
Placebo
Not 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
Dr.Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-10-21, 1397/07/29
Ethics committee reference number
IR.ZAUMS.REC.1397.297
Health conditions studied
1
Description of health condition studied
Normal Tension Glaucoma
ICD-10 code
H40
ICD-10 code description
Glaucoma
Primary outcomes
1
Description
IOP (intraocular pressure ) mmhg
Timepoint
At the beginning of the study, Then 3 months, 6 months, 9 months and 12 months after initiating medications.
Method of measurement
The Air puff tonometer Topcon
2
Description
Laminar and prelaminar thickness of lamina cribrosa using OCT of optic nerve head(ONH)
Timepoint
At the beginning of the study, Then 3 months, 6 months, 9 months and 12 months after initiating medications.
Method of measurement
laminar and prelaminar thickness of optic nerve head using cirrus OCT
3
Description
visual field defect / number of scotomas and in decibels
Timepoint
At the beginning of the study, 6 months, and 12 months after initiating medications.
Method of measurement
Humphrey field analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Prescription of eyedrop Brimonidine 0.2% made in Iranian Sina daroo inc, every 12 hours in the eye
Category
Treatment - Drugs
2
Description
Intervention group 2: Prescription of Eyedrop latanoprost 0.005% made in Iranian Sina daroo inc. once daily at 9 PM in the eye
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Eye hospital
Full name of responsible person
Hamid Vaezi
Street address
Shahid Motahar Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Email
Mahichmanegah_121@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nour Mohammad Bakhshani
Street address
Dr Hesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
zaums.research@gmail.com
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
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
Zahedan University of Medical Sciences
Full name of responsible person
Hamid Vaezi
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahari Blvd. Alzahra eye hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
Mahichmanegah_121@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arish
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Motahar Blvd. Alzahra eye hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
098 54 33219915
Email
Arish.mohammed@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamid Vaezi
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahari Blvd. Alzahra eye hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
Mahichmanegah_121@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available