A comparison changing short time intraocular pressure (IOP) fluctuation in intravitreal bevacizumab injection with and without acetazolamide oral drug in amir almomenin hospital, A clinical trial study
To determine the impact oral Acetazolamide in changing short time intraocular pressure (IOP) fluctuation in intra vitreous bevacizumab injection
Design
340 eyes of patients who were injected intravitreous bevacizumab were assigned randomly into 2groups with 170 eyes in each group.
Group1 receiving oral Acetazolamide 250 mg half hour time before intravitreous bevacizumab injection from Mehr darou company
Second group dont receive oral Acetazolamide before intravitreous bevacizumab injection.
Settings and conduct
This study is clinical trial with control group the study will be conducted in the eye clinic of Amiralmomenin hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all of the patients with a eye disease need to intravitreous bevacizumab injection in amiralmomnin hospital.
Non Inclusion criteria: patients with a history of glaucoma¸ glaucoma surgery ¸scleral buckle¸ deep vitrectomy¸ iris neovascularization and history of anti glaucoma drug excluded in this study.
Intervention groups
Intervention group:Patients in Intervention groups at first measuring intraocular pressure with Tonometry slit lamp. Then receiving oral Acetazolamide 250mg ,30 minutes before intravitreous bevacizumab Injection and then 2-3 hours after injection, measuring Intraocular pressure with Tonometry and compared with control group.
Control group: First measuring Intraocular pressure with Tonometry slit lamp. Before intravitreous bevacizumab Injection and no receiving oral Acetazolamide and then 2-3 hours after intravitreous bevacizumab Injection Remeasuring Intraocular pressure with Tonometry slit lamp and compared with Intervention group.
Main outcome variables
Intraocular pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210408050895N1
Registration date:2021-06-20, 1400/03/30
Registration timing:registered_while_recruiting
Last update:2021-06-20, 1400/03/30
Update count:0
Registration date
2021-06-20, 1400/03/30
Registrant information
Name
hasan behboudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 6886
Email address
behboudi_dr@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison changing short time intraocular pressure (IOP) fluctuation in intravitreal bevacizumab injection with and without acetazolamide oral drug in amir almomenin hospital, A clinical trial study
Public title
To determine the impact oral Acetazolamide in changing short time intraocular pressure (IOP) fluctuation in intra vitreous bevacizumab injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all of the patients with a eye disease need to intra vitreous bevacizumab injection in amiralmomnin hospital
Exclusion criteria:
patients with a history of glaucoma ¸ glaucoma surgery
scleral buckle ( SB)
deep vitrectomy (Vitx)
iris neovascularization (NI)
history of anti-glaucoma drug
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
340
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who were included were assigned randomly in 2 groups.
Group A: patients receiving oral Acetazolamide 250 mg half hour time before intra vitreous Bevacizumab injection.
Group B: patients with no receiving oral Acetazolamide before intra vitreous Bevacizumab injection
The ward nurse randomly and without information from primary disease of patient give half of them oral Acetazolamide 250mg and half of them not receiving oral Acetazolamid and then entering groups.
Blinding (investigator's opinion)
Not 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 Giulan University of Medical Sciences
all of the patients with a eye disease need to intravitreous bevacizumab injection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
intraocular pressure
Timepoint
half an hour before injecting bevacizumab in vitrous and three hours after injection
Method of measurement
Tonometer Asylum Lamp
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in Intervention groups at first measuring intraocular pressure with Tonometry slit lamp. Then receiving oral Acetazolamide 250mg , 30 minutes before intravitreous bevacizumab injection and then 2-3 hours after intravitreous bevacizumab Injection measuring Intraocular pressure with Tonometry and compared with control group.
Category
Treatment - Drugs
2
Description
Control group: Patients in Control groups at first measuring Intraocular pressure with Tonometry slit lamp. Before intravitreous bevacizumab Injection and no Receiving oral Acetazolamide and then 2-3 hours after intravitreous bevacizumab Injection Remeasuring Intraocular pressure with Tonometry slit lamp and compared with Intervention group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Hasan Behboudi
Street address
Eye Research Center, Department of Eye, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
City
Rasht
Province
Guilan
Postal code
4136937459
Phone
+98 13 3323 8308
Email
eye.rcgilan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Naghipour
Street address
Deputy of Research and Technology of Guilan University of Medical Sciences- in front of 17 Shahrivar Hospital– Shahid Siadati Ave.– Namjoo St.– RASHT- IRAN
City
Rasht
Province
Guilan
Postal code
4136937459
Phone
+98 21 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?