A Comparative Study of the Effect of Zilomol and Timolol Drop Following Intravitreal Injection of Bevacizumab on the Improvement of Diabetic Macular Edema
- Determination and comparison of visual acuity after intravitreal injection of bevacizumab in two study groups before and after the intervention.
2-Determination and comparison of the average central thickness of the macula in the intravitreal injection of bevacizumab in the two study groups before and after the intervention.
3-Determining and comparing the average intravitreal eye pressure of bevacizumab in the two study groups before and after the intervention.
Design
A clinical trial with two intervention groups, community-based and practice-oriented, triple-blind, parallel, randomized
Settings and conduct
The population studied in the current research will be patients with diabetic macular edema who referred to Al-Zahra Ophthalmology Hospital in 1402. Sampling will be available to enter the study, and to receive the type of treatment, random sampling
* The type of randomization is simple randomization. It will continue using the table of random numbers until the sample size is completed in each group.
*Blinding: It is triple blind, the patient is not aware of the type of intervention performed, and on the other hand, the doctor evaluating the outcome of the study is also not aware of the type of treatment used. The statistical consultant is also not aware of the type of intervention.
*Allocation concealment is done by using "sealed and waxed opaque envelopes with a random sequence".
Participants/Inclusion and exclusion criteria
The study population in the current research will be patients with diabetic macular edema who referred to Al-Zahra Ophthalmology Hospital in 1402.
Intervention groups
Zilamol drop
Timolol drop
Main outcome variables
VA IOP central thickness of macula
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231126060185N1
Registration date:2024-01-09, 1402/10/19
Registration timing:prospective
Last update:2024-01-09, 1402/10/19
Update count:0
Registration date
2024-01-09, 1402/10/19
Registrant information
Name
Maryam Dianat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5725
Email address
dianatmaryam60@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Effect of Zilomol and Timolol Drop Following Intravitreal Injection of Bevacizumab on the Improvement of Diabetic Macular Edema
Public title
The Effect of Zilomol and Timolol Drop on the Diabetic Macular Edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with bilateral diabetic macular edema (central retinal thickness more than 300 microns) with center-involved and thickness difference less than 25% between 2 eyes who have not undergone any eye interventions (such as eye surgery, intraocular injection) eye, eye lasers and eye treatment and eye local treatment) are not included.
Exclusion criteria:
Patients during pregnancy and breastfeeding
Active intraocular inflammation treated with topical corticosteroids
Eye pathologies such as pterygium or corneal opacities that can affect the evaluation of study variables
A patient with high eye pressure who is treated with intraocular pressure lowering drugs and corticosteroids
History of allergy to CAIs and sulfonamide drugs
Patients who use systemic antihypertensive drugs such as acetazolamide or beta blockers
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
34
More than 1 sample in each individual
Number of samples in each individual:
2
RIGHT AND LEFT EYE
Randomization (investigator's opinion)
Randomized
Randomization description
For each patient, one of the eyes is randomly selected to receive dorzolamide-timolol drops (Zimolol) and the opposite eye receives timolol drops at a dose of one drop every 8 hours.
The label of the drops is removed in order to make their shape uniform and the drops are coded with random three-digit numbers (391 and 538) (code 391: dorzolamide-timolol drops/code 538: timolol drops). The person injecting is unaware of which eye the patient is using dorzolamide-timolol and which timolol. At the end, the statistics expert will be presented with the information related to BCVA, CMT and IOP of both eyes in coded form (code 391 and 538).
Blinding (investigator's opinion)
Triple blinded
Blinding description
It is blinded in three ways, the patient is not aware of the type of intervention performed, and on the other hand, the doctor evaluating the outcome of the study is also not aware of the type of treatment used. The statistical consultant is also not aware of the type of intervention. Opaque sealed with random sequence is done. In this way, the random sequence is determined first, then the sequences are recorded on a card and the cards are placed inside the envelopes in order. On the outer surface of the envelopes. The numbering is done and it is placed in the box in order. The participants choose an envelope in the order of arrival and the intervention group is determined.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan university of medical Sciences
Street address
Motahhary Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Approval date
2023-10-17, 1402/07/25
Ethics committee reference number
IR.ZAUMS.REC.1402.315
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy is one of the most important causes of blindness in the world, and due to the fact that it affects people of working age, it has tremendous socio-economic consequences in societies. (1) The prevalence of DME in diabetic patients in Iran is estimated to be around 30%. (DME, Diabetic Macular Edema) can be defined as macular thickening and cystoid edema, which can cause diabetic retinopathy mostly with exudate deposition.
ICD-10 code
E08.321
ICD-10 code description
Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema
Primary outcomes
1
Description
Central thickness of macula
Timepoint
Before intervention-1month -2month-3month post IVB and drop
Method of measurement
- measurement using macular OCT imaging
2
Description
IOP
Timepoint
Before intervention-1month -2month-3month post IVB and drop
Method of measurement
measurement by Goldman tonometer
Secondary outcomes
1
Description
Visual acuity
Timepoint
Before intervention and one ,two,three month post
Method of measurement
LogMar
Intervention groups
1
Description
Intervention group 1: the eye receiving xylomol drops. One day before the intravitreal injection of bevacizumab, drops are placed every 8 hours in the eye that will be injected, and after the injection, they continue every 8 hours for one month and thus To be injected three times and to use intravitreous drops for one month after injection. And after each month of injection, visual acuity, intraocular pressure and central thickness of the macula are measured
Category
N/A
2
Description
Intervention group: the second eye, recipient of timolol drops, is performed in the same way as the first intervention group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Maryam Diant
Street address
Motahhary street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Email
Dianatmaryam89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Motahhary Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Phone
+98 919 346 7860
Email
Dianatmaryam89@gmail.com
Grant name
Vice President of Research and Research of Zahedan University of Medical Sciences
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
Maryam Dianat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahhary
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Phone
+98 54 3329 5725
Fax
Email
dianatmaryam60@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Dianat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahhary
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Phone
+98 54 3329 5725
Fax
Email
dianatmaryam60@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Dianat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahhary
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Phone
+98 54 3329 5725
Fax
Email
dianatmaryam60@gmail.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