Comparing the effect of near confluent laser versus combination of less dense laser and bevacizumab on prethreshold Retinopathy of prematurity (ROP) type 1 zone 2: Randomized clinical trial
To compare the rate of progression and re-treatment between two methods
Design
Two arm parallel group , double blinded randomized clinical trial on 43 patients using randomization chart
Settings and conduct
1- ROP clinic in Poostchi Eye Institute in Shiraz (the place of study accomplished)
2- type1 prethreshold ROP (sample population)
3- prospective double blinded randomized clinical trial using randomization chart ( kind and way of making blind)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Neonates with retinopathy of prematurity; type 1 prethreshold, zone 2 location.
Exclusion criteria: Threshold Retinopathy of prematurity(ROP) ; ROP stage 4-5; vitreous hemorrhage; neovascularization of iris; aggressive posterior ROP; elevated ridge
Intervention groups
Intervantion group: less dense laser and intravitreal bevacizumab injection
control group: Dense laser photocoagulation
Main outcome variables
Rate of vascularization progression; Rate of re-treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201120049450N1
Registration date:2021-12-27, 1400/10/06
Registration timing:registered_while_recruiting
Last update:2021-12-27, 1400/10/06
Update count:0
Registration date
2021-12-27, 1400/10/06
Registrant information
Name
Ehsan Namvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 4088
Email address
namvar_e@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-04, 1400/08/13
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of near confluent laser versus combination of less dense laser and bevacizumab on prethreshold Retinopathy of prematurity (ROP) type 1 zone 2: Randomized clinical trial
Public title
Combined laser and bevacizumab in ROP treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Retinopathy of prematurity
Type 1 prethreshold
location: Zone 2 of retina (from posterior circle to nasal ora serrata)
Exclusion criteria:
elavated demarcation ridge
vitreous hemorrhage
threshold
zone 1
neovascularization of iris
Age
From 1 month old to 4 months old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Patients included in the study were divided into patient and control groups based on a random number table.
The table of random numbers starts from number 1 and is in the form of sequences that for example put number 1 as A and number 2 as A, number 3 to number 8 as B and ...
This is a global standard table where group A can be considered a case and group B can be considered a control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ophthalmologist team (those who exam and follow the neonates) are unaware of the group of patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Poostchi street, Poostchi eye clinic
City
Shiraz
Province
Fars
Postal code
7193616641
Approval date
2021-11-04, 1400/08/13
Ethics committee reference number
IR.SUMS.REC.1399.1302
Health conditions studied
1
Description of health condition studied
Retinopathy of prematurity
ICD-10 code
H35.109
ICD-10 code description
Retinopathy of prematurity, unspecified, unspecified eye
Primary outcomes
1
Description
Regression and progression of vascularization
Timepoint
Monthly up to 6 months
Method of measurement
Fundus examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combined less dense laser and intravitreal Bevacizumab(dosage: 0.625micro). This combination treatment is performed in Khalili's operating room with prior reservation from the NICU. The next day after the operation, the baby is examined and then weekly for up to 4 weeks and the last examination after 24 weeks. At each stage, the stage of the disease is measured, and in case of regression of the stage and reduction of abnormal arteries, no new intervention is needed.
Category
Treatment - Drugs
2
Description
Control group: dense laser treatment. This treatment is performed in Khalili's operating room with prior reservation from the NICU. The next day after the operation, the baby is examined and then weekly for up to 4 weeks and the last examination after 24 weeks. At each stage, the stage of the disease is measured, and in case of regression of the stage and reduction of abnormal arteries, no new intervention is needed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Poostchi eye clinic
Full name of responsible person
Ehsan Namvar
Street address
Poostchi Eye clinic; Poostchi street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3230 2830
Email
Namvar.e@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar and Mohammadhosein Norouzzadeh
Street address
Shiraz University of Medical Sciences; in front of Felestin avenue; Zand street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1779
Email
Namvar.e@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Poostchi eye clinic, Poostchi street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1779
Email
Namvar.e@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar
Position
assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Poostchi eye clinic, Poostchi street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3230 2830
Email
Namvar.e@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar
Position
assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Poostchi eye clinic, Poostchi street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1779
Email
Namvar_e@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Outcomes of near confluent laser versus combined less dense laser and bevacizumab treatment of prethreshold ROP type 1 zone 2: Randomized clinical trial
When the data will become available and for how long
2021
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
If poostchi-eye research center permitted
From where data/document is obtainable
poostchi-eye research center
What processes are involved for a request to access data/document