Comparison of effect of Conventional and Optical coherence tomography Angiography-guided laser Photocoagulation to treatment of focal diabetic macular edema
Comparison of effect of Conventional and Optical coherence tomography Angiography-guided laser Photocoagulation to treatment of focal diabetic macular edema
Design
Patients referred to the clinic during one year who have focal macular edema due to diabetes and are indicated for treatment, are easily divided into two groups by simple sampling method without blindness and one in between. The number of samples is 40 people who are in two groups of 20. Randomizer software was used for randomization.
Settings and conduct
Tabriz Nikoukari Eye Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetic patients referred to charity hospital with focal macular edema who are treated according to clinically significant macular edema criteria.
Exclusion criteria: History of any retinal laser therapy; history of intraocular injection of anti-VEGF in the previous three months; evidence of severe macular ischemia on angiography
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Intervention groups
After the initial examination and initial BCVA recording and initial OCT, patients are randomly divided into two groups. In the first group, without OCT-A, patients are treated with macular laser. Laser specifications include yellow wavelength duration: 0.1 and power between 80 to 150 and spot size is 50 micrometers, which is done at intervals of one spot in edematous areas. The goal is to change the light color to light gray in the laser-treated areas. In this group, we use the yellow wavelength with a duration: 0.1 and spot size: 50 micrometers with an intensity between 80 to 150 in the areas of microaneurysms. The goal is to change the light gray color in the place of microaneurysms.
Main outcome variables
Visual acuity; Macular thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210529051430N1
Registration date:2021-06-09, 1400/03/19
Registration timing:prospective
Last update:2021-06-09, 1400/03/19
Update count:0
Registration date
2021-06-09, 1400/03/19
Registrant information
Name
farideh mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3657 7330
Email address
mousavif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Conventional and Optical coherence tomography Angiography-guided laser Photocoagulation to treatment of focal diabetic macular edema
Public title
Laser treatment of macular edema with the help of angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients
Focal macular edema
Indication of treatment according to clinically significant macular edema criteria
Exclusion criteria:
History of any retinal laser
History of intraocular injection of anti-VEGF in the last three months
Evidence of severe macular ischemia on angiography
History of regional steroid injection in the last 4 months
The presence of subfoveal edema
Impossibility of laser due to insufficient vision
History of any eye disease other than retinopathy, including uveitis glaucoma, degenerative diseases, and dystrophies
Pregnant and lactating women
Existence of diabetic nephropathy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
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
Translation results University Committee of Ethics in Research, Tabriz University of Medic
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۶۴۵۳۹۵
Approval date
2021-04-12, 1400/01/23
Ethics committee reference number
IR.TBZMED.REC.1400.048
Health conditions studied
1
Description of health condition studied
Macular edema caused by diabetes
ICD-10 code
E08.311
ICD-10 code description
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
Primary outcomes
1
Description
Patient vision
Timepoint
two months
Method of measurement
For this purpose, we analyze the data obtained from visual acuity based on LOGMAR between the two groups.
Secondary outcomes
1
Description
macular thickness
Timepoint
two months
Method of measurement
data collected from macular thickness based on microns using INDEPENDENT SAMPLE T TEST method between the two groups.
Intervention groups
1
Description
First group: patients undergo macular laser treatment without OCT-A. Laser specifications include yellow wavelength duration: 0.1 and power between 80 to 150 and spot size 50 micrometers, which is done at intervals of one spot in edematous areas. The goal is to change the color light to light gray in the laser areas
Category
Treatment - Surgery
2
Description
Second group: After performing the OCT-A and locating the microaneurysms, laser therapy is performed. In this group, we use the yellow wavelength with duration: 0.1 and spot size: 50 micrometers with an intensity between 80 and 150 in the areas of microaneurysms. Light gray is present at the site of microaneurysms. Patients are followed up three times after the laser, at two-month intervals, including BCVA measurements and OCT. After collecting the data, they are analyzed and statistically analyzed
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Nikoukari Eye Hospital
Full name of responsible person
dr.Farideh Mousavi
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۶۴۵۳۹۵
Phone
+98 41 3657 7330
Email
mousavif@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۶۴۵۳۹۵
Phone
+98 41 3335 7310
Email
samieim@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farideh Mousavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۶۴۵۳۹۵
Phone
+98 41 3657 7330
Email
mousavif@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farideh Mousavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۶۴۵۳۹۵
Phone
+98 41 3657 7330
Email
mousavif@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hadi Zandian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۶۴۵۳۹۵
Phone
+98 41 3657 7330
Email
hadizandiyan65@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