Evaluation and comparison of macular vessel density after pars plana vitrectomy with and without internal limiting membrane Peeling in severe diabetic retinopathy patients
Evaluation and comparison of macular vessel density after pars plana vitrectomy with and without internal limiting membrane Peeling in severe diabetic retinopathy patients
Design
Clinical trial with intervention and control groups, each group includes 25 patients and a total of 50 patients are examined.
Sampling is non-random and accessible
Settings and conduct
Patients referred to Isfahan Faiz Ophthalmology Hospital who were diagnosed with diabetic retinopathy with the non-clearing vitreous hemorrhage who filled in inclusion criteria were randomly assigned to the intervention or control group and underwent vitrectomy surgery with or without ILM peeling which is the intended intervention. Then, patients will be followed by phone calls to perform relevant examinations and imaging.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diabetic retinopathy patients with non-clearing vitreous hemorrhage who were over 30 years old and without retinal detachment.
Exclusion criteria:
Patients with retinal detachment
Avastin (Anti-VEGF) injection indication before or after surgery
Intervention groups
intervention group:
Diabetic retinopathy patients with non-clearing vitreous hemorrhage underwent vitrectomy surgery with internal limiting membrane peeling.
control group:
Diabetic retinopathy patients with non-clearing vitreous hemorrhage underwent vitrectomy surgery without internal limiting membrane peeling.
Main outcome variables
macular vessel density
General information
Reason for update
Acronym
ilm
IRCT registration information
IRCT registration number:IRCT20240102060596N1
Registration date:2024-03-13, 1402/12/23
Registration timing:registered_while_recruiting
Last update:2024-03-13, 1402/12/23
Update count:0
Registration date
2024-03-13, 1402/12/23
Registrant information
Name
Rasoul Etesam por
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3224 8034
Email address
dr.rasouletesampor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of macular vessel density after pars plana vitrectomy with and without internal limiting membrane Peeling in severe diabetic retinopathy patients
Public title
Evaluation and comparison of macular vessel density after pars plana vitrectomy with and without internal limiting membrane Peeling in severe diabetic retinopathy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic Retinopathy patients with non-clearing vitreous hemorrhage without retinal detachment
Patients should be 30 years old or older
Exclusion criteria:
retinal detachment
Anti VEGF injection indication
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is aware of entering the study, but does not know whether he will be in the intervention group or the control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical sciences
Street address
Hezar jerib ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.ARI.MUI.REC.1402.252
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy
ICD-10 code
E11.3519
ICD-10 code description
Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye
Primary outcomes
1
Description
macular vessel density
Timepoint
1 & 3 months after vitrectomy with and without internal limiting membrane peeling
Method of measurement
OCTA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pars plana vitrectomy with internal limiting peeling which is performed during vitrectomy after ilm staining with trypan dye and peeling with gage 23 ilm griping forceps.
Category
Treatment - Surgery
2
Description
Control group: pars plana vitrectomy without ILM peeling
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Mohammad Malek Ahmadi
Street address
Modares ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2033
Email
ierc@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Malek Ahmadi
Street address
Modares ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2033
Email
irec@mui.med.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rasoul Etesam Por
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Feiz hospital, modares ave, isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 2033
Email
ierc@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Malek Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modares ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2033
Email
mmalekahmadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasoul Etesam por
Position
پزشک عمومی
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Feiz hospital, Modares ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2033
Email
dr.rasouletesampor@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
confedentiality
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
anonymous data
When the data will become available and for how long
1 year after article published
To whom data/document is available
Feiz hospital ophthalmology research center
Under which criteria data/document could be used
further assessment and research
From where data/document is obtainable
Feiz hospital ophthalmology research center
What processes are involved for a request to access data/document