Comparison amount of optic head vesel density in micropulse and conventional befor and after photocoagulation
Design
One arm parallel group randomised in 50 eye, each group divide 25 eye, randomized trial with single randomization, odd numbers and even numbers
Settings and conduct
Alzahra eye hospital in Zahedan, after visits all pation ,diveide 2 group patients and under photocoagulation, pation do not know wich photocoagulation done.
Participants/Inclusion and exclusion criteria
Inter- non proliferation diabetes patients with macula edema
No inter- patient with intra vitre injections
Intervention groups
First Intervention group for conventional photocoagulation and second Intervention group for micropulse photocoagulation these photocoagulation for improve macula edema, this study for effect of photocoagulations in optic head perfusion.
Main outcome variables
Vessel density and perfusion optic head
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221026056315N1
Registration date:2023-01-28, 1401/11/08
Registration timing:prospective
Last update:2023-01-28, 1401/11/08
Update count:0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Maryam Zeighami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 8337
Email address
maryamzeighami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of optic nerve head perfusion in diabetic patients undergo conventional and micropulse macular photocoagulation
Public title
Comparison of optic nerve head perfusion in diabetic patients undergo conventional and micropulse macular photocoagulation in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
non proliferative diabetic retinopathy patients with macula edema
Exclusion criteria:
Intravitrea drug injection
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Use simple randomization,use the table of random number, even number will be assigned to micropulse intervention and odd number to conventional. Randomization unit individual
Blinding (investigator's opinion)
Double blinded
Blinding description
People from the research team who are responsible for the selection and randomization of patients will not be included in the other stages of the research, especially the examination of people in terms of the dependent variable. Also, the consent form was filled and the procedure was explained, the patients and their companions will divided without knowing that they were in the intervention or control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan university of medical sciences
Street address
Alzahra eye hospital, Motaheri steet
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Approval date
2022-09-18, 1401/06/27
Ethics committee reference number
۳۲۱۲-س-پ-۸/۲-۱۴۰۱
Health conditions studied
1
Description of health condition studied
Non proliferation diabetic patients with macula edema
ICD-10 code
E08.341
ICD-10 code description
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema
Primary outcomes
1
Description
Optic head perfusion
Timepoint
Befor conventional and micropulse photocoagulation -one month, 3 month and 6 month after conventional and micropulse photocoagulated
Method of measurement
Optical coherence tomography angiography(OCTA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1 : Diabetic pations with macula edema one time under micropulse photocoagulation. This device (manufactured by Quantel Medial, USA) will be used with an adjustable power starting at 1000 mV with a duration of 300 µs and a duty cycle of 15% and a spot size of 500 µm.
Category
Treatment - Other
2
Description
Intervention group2: Diabetic pations with macula edema one time under convetional photocoagulation. Conventional laser photocoagulation (Quantel-medical Co, USA) will be performed via dilated pupil in eyes of second group as described below: adjustable power with 50 to 100 microns spot size, 0.1 second duration time. Focal laser will be applied in distance of 500 to 3000 microns of the foveal avascular zone (FAZ) and also on microvascular lesions of the exudative ring, also grid laser will be applied on thickened retinal areas in 500 microns distance of the FAZ and 500 microns distance of temporal ridge of optic disc.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra eye hospital Zahedan
Full name of responsible person
Maryam Zeighami
Street address
Alzahra eye hospital, Motaheri street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 935 083 2808
Email
Maryamzeighami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
University
Street address
Zahedan university of medical sciences,Dr Hesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3344 6251
Email
public@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
Maryam Zeighami
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No.48, Shohada street.
City
Ardabil
Province
Ardabil
Postal code
5619745741
Phone
+98 45 3323 8337
Fax
Email
maryamzeighami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Zeighami
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No.48, Shohada street
City
Ardabil
Province
Ardabil
Postal code
5619745741
Phone
+98 45 3323 8337
Fax
Email
maryamzeighami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Zeighami
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No.48, Shohada street
City
Ardabil
Province
Ardabil
Postal code
5619745741
Phone
+98 45 3323 8337
Fax
Email
maryamzeighami@yahoo.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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available