Determining the prophylactic effect of antiglaucoma drugs on eye pressure in patients undergoing intravitreal injection of bevacizumab
Design
A controlled, single-blind, randomized, phase 3 clinical trial on 108 patients. R statistical software version 4.0.2 was used for randomization
Settings and conduct
The study population in this research is all patients who are candidates for intravitreal injection of bevacizumab referred to Al-Zahra Ophthalmology Hospital.
In this research, single blinding method is used. So that the person responsible for recording the results (eye resident) will not be aware of the desired intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
1- Age more than 18 years
2- Informed and free consent to participate in the study
3- Patients who will have the first intra-boasizomat injection.
Exclusion criteria also include:
1- History of retinal surgery
2- Rupture of the posterior capsule
3- High eye pressure or glaucoma
4- Use of topical medication
5- Active intraocular inflammation
6- Eye pathologies
7- Withdrawal from the study during research for any reason
Intervention groups
Patients were randomly divided into 4 groups, group A: topical timolol 0.5% (2 drops with a time interval of 10 minutes, 60-90 minutes before intervention), group B: combination of dorzolamide hydrochloride 2% and timolol maleate 0.5% and brand name Xylomol® (2 drops with an interval of 10 minutes, 60-90 minutes before the intervention), group C: oral acetazolamide 500 mg (90-120 minutes before the intervention), group D: placebo drop group (one drop artificial tears, which will be administered 2 drops with an interval of 10 minutes, 60-90 minutes before the intervention) will be divided
Main outcome variables
Intraocular pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230330057787N1
Registration date:2023-09-04, 1402/06/13
Registration timing:prospective
Last update:2023-09-04, 1402/06/13
Update count:0
Registration date
2023-09-04, 1402/06/13
Registrant information
Name
fatemeh asli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 9705
Email address
fateme813@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the prophylactic effect of antiglaucoma drugs on eye pressure in patients undergoing intravitreal injection of bevacizumab
Public title
effect of anti-glaucoma agents on intra ocular pressure Spikes after intravitreal bevacizumab injection in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Age more than 18 years
2- Informed and free consent to participate in the study
3- Patients who will have the first intra-boasizomat injection.
Exclusion criteria:
1- History of retinal surgery.
2- Rupture of the posterior capsule
3- High eye pressure or glaucoma
4- Use of topical medication (such as IOP-lowering medications and corticosteroids)
5- Active intraocular inflammation
6- Eye pathologies such as pterygium or corneal opacities that can affect the evaluation of study variables
7- Withdrawal from the study during research for any reason
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to 5 groups is done by permuted stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of arrival. Then they are randomly assigned to the desired group. These permutations were created using statistical software R version 4.0.2
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, single blinding method is used. So that the person responsible for recording the results (eye resident) will not be aware of the intended intervention.
Placebo
Used
Assignment
Other
Other design features
A controlled, single-blind, randomized, phase 3 clinical trial on 108 patients. R statistical software version 4.0.2 was used for randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan - Doctor Hasabi Square - Medical Sciences Campus
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.ZAUMS.REC.1401.433
Health conditions studied
1
Description of health condition studied
Eye pressure of patients undergoing intravitreal injection of bevacizumab
ICD-10 code
H40.6
ICD-10 code description
Glaucoma secondary to drugs
Primary outcomes
1
Description
Intraocular pressure
Timepoint
The beginning of the study / one minute after injection / 30 minutes after injection / 24 hours after injection
Method of measurement
At the beginning of the study, 30 minutes after the injection and 24 hours after the injection, the intraocular pressure is measured with a Goldman tonometer and one minute after the injection with Tonopen.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, 0.5% topical timolol drops (2 drops with a 10-minute interval, 60-90 minutes before the intervention) are prescribed.
Category
Treatment - Drugs
2
Description
Intervention group: In the second group, the combination of dorzolamide hydrochloride 2% and timolol maleate 0.5% with the brand Xylomol® (2 drops with a time interval of 10 minutes, 60-90 minutes before the intervention) is prescribed.
Category
Treatment - Drugs
3
Description
Intervention group: In the third group, oral acetazolamide 500 mg is administered (90-120 minutes before the intervention).
Category
Treatment - Drugs
4
Description
Control group: In this group, placebo drops (an artificial tear drop, 2 drops with a time interval of 10 minutes, 60-90 minutes before the intervention) are prescribed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Ophthalmology Hospital
Full name of responsible person
Mr. Dr. Mohammad Erish
Street address
Zahedan Motahari Blvd. has not reached Khatam Square of Al-Zahra Ophthalmology Hospital
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Fax
+98 54 3323 3550
Email
ALzahra_eyecenter@yahoo.com
Web page address
http://eye.zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nur Mohammad Bakhshani
Street address
Zahedan Square, Dr. Hasabi Campus, University of Medical Sciences
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Fax
+98 54 3329 5771
Email
info@zaums.ac.ir
Web page address
https://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
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
Mr. Dr. Mohammad Erish
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Zahedan Motahari Blvd. has not reached Khatam Square of Al-Zahra Ophthalmology Hospital
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۳۷۷۸۹
Phone
+98 54 3321 9915
Fax
+98 54 3323 3550
Email
ALzahra_eyecenter@yahoo.com
Web page address
http://eye.zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mr. Dr. Mohammad Erish
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Zahedan Motahari Blvd. has not reached Khatam Square of Al-Zahra Ophthalmology Hospital
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Fax
+98 54 3323 3550
Email
ALzahra_eyecenter@yahoo.com
Web page address
https://eye.zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mr. Dr. Mohammad Erish
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Zahedan Motahari Blvd. has not reached Khatam Square of Al-Zahra Ophthalmology Hospital
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Fax
+98 54 3323 3550
Email
ALzahra_eyecenter@yahoo.com
Web page address
https://eye.zaums.ac.ir
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