Title: Brimonidine 0.2% versus Betaxolol 0.5% prophylactic effect on IOP elevation after Nd: YAG Laser posterior capsulotomy
Design
A clinical trial study with parallel, double-blind, randomized groups
Settings and conduct
In the specialized and sub-specialized polyclinic of Semnan University of Medical Sciences, eligible patients are randomly divided into two groups of 20 based on block design. First, the pupils are dilated with Midrax 0.5% eye drop, and then in group 1, one hour before the laser, a drop of 0.2% brimonidine and in group 2, a drop of 0.5% betaxolol are poured into the lower fornix by the nurse, and the patient close his eyes for one minute. The patient does not know the type of drug (betaxolol or brimonidine). Patients' eye pressure is measured and recorded by a specialist one hour before surgery and four hours after. The doctor also does not know the type of drug used. The analysis of the information collected is done by an assistant professor of biostatist who does not know the drug used in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients with posterior capsule opacity following uncomplicated cataract surgery
2. Age over 21 years
exclusion criteria:
1. Patients with glaucoma (and its history of surgery), active inflammation, infection, and any ocular or systemic disease that causes a direct or indirect increase in intraocular pressure.
2. Patients taking systemic clonidine, topical apraclonidine or brimonidine, systemic or topical prostaglandins, and NSAIDs and systemic beta-blockers.
Intervention groups
In group 1, a drop of 0.2% brimonidine is poured one hour before the laser and in group 2, a drop of 0.5% betaxolol is poured into the lower fornix.
Main outcome variables
Title: Brimonidine 0.2% versus Betaxolol 0.5% prophylactic effect on IOP elevation after Nd: YAG Laser posterior capsulotomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200901048577N1
Registration date:2020-09-23, 1399/07/02
Registration timing:retrospective
Last update:2020-09-23, 1399/07/02
Update count:1
Registration date
2020-09-23, 1399/07/02
Registrant information
Name
Elnaz Saber
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3386 2847
Email address
lnaz_saber@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title: Brimonidine 0.2% versus Betaxolol 0.5% prophylactic effect on IOP elevation after Nd: YAG Laser posterior capsulotomy
Public title
Title: Brimonidine 0.2% versus Betaxolol 0.5% effect on IOP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with PCO after cataract surgery
above 21 years old
Exclusion criteria:
patients with glaucoma (and history of surgery), active inflammation, infection, and any ocular or systemic disease that directly or indirectly increases intraocular pressure
If patients taking systemic clonidine, topical apraclonidine or brimonidine, systemic or topical prostaglandins, and NSAIDs and systemic beta-blockers.
Age
From 21 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization , In this study, the randomized permutation block method is used to divide the participants into two groups. Each block will have 4 units (2 units related to intervention and 2 units related to comparison) Due to the permutation of 4 units, we will have a total of 6 types of blocks, which are identified by numbers 1 to 6. Using the table of random numbers corresponding to the numbers 1 to 6, one of the above 6 blocks is selected and the numbers 0, 7, 8 and 9 are not considered. In this way, patients are balanced into two groups of intervention and comparison.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly divided into two groups of 20 based on block design. In group 1, a drop of 0.2% brimonidine is given one hour before the laser, and in group 2, a drop of 0.5% betaxolol is poured into the lower fornix by the nurse, and the patient does not know the type of drug (betaxolol or brimonidine). Patients' eye pressure is measured and recorded by a specialist one hour before surgery and four hours after. The doctor also does not know the type of drug used. The analysis of the information collected is done by an assistant professor of biostatist who does not know the drug used in the two groups. The information collected by the physician and nurse and the information obtained from the analysis are given to the student responsible for drafting the article.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Golestan town, Amin street, Kosar hospital
City
semnan
Province
Semnan
Postal code
3519899951
Approval date
2020-08-05, 1399/05/15
Ethics committee reference number
IR.SEMUMS.REC.1399.142
Health conditions studied
1
Description of health condition studied
posterior capsule opacification
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
intraocular pressure
Timepoint
1 hour before YPC surgery and 4 hours after surgery
Method of measurement
Goldmann Applanation tonometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: One hour before YPC surgery, first the eyes are dilated with a drop of 0.5% mydriax, then a drop of 0.2% brimonidine is poured into the lower fornix of the eyes.
Category
Treatment - Drugs
2
Description
Intervention group 2: One hour before YPC surgery, first the eyes are dilated with a drop of 0.5% mydriax, then a drop of 0.5% betaxolol is poured into the lower fornix of the eyes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Dr navid Elmi Sadr
Street address
Golestan town , Amin street
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Email
kosarhos@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz kokhayi
Street address
Golestan town , amin street , kosar hospital
City
Semnan
Province
Semnan
Postal code
۳۵۱۹۸۹۹۹۵۱
Phone
+98 23 3344 1022
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Elnaz Saber
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golestan town , Amin street , Kosar hospital
City
Semnan
Province
Semnan
Postal code
۳۵۱۹۸۹۹۹۵۱
Phone
+98 23 3344 1022
Email
Lnaz_saber@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Navid Elmi Sadr
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Golestan town , Amin street , Kosar hospital
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Email
navid.elmi.sadr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elnaz Saber
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golestan town , Amin street , Kosar hospital
City
Semnan
Province
Semnan
Postal code
۳۵۱۹۸۹۹۹۵۱
Phone
+98 23 3344 1022
Email
Lnaz_saber@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
تمامی داده ها پس از غیرقابل شناسایی شدن افراد قابل اشتراک گذاری می باشد
When the data will become available and for how long
After printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
Contact the person in charge of public information of the project by e-mail
What processes are involved for a request to access data/document
After sending the e-mail, if the person is eligible, the data will be sent