Comparison of two methods of combined less dense laser and bevacizumab treatment of prethreshold ROP type 1 zone 2 (stair method):a randomized controlled trial
Comparison of two methods of combined less dense laser and bevacizumab in patients with retinopathy of prematurity type 1 zone 2
Design
Clinical trial with two groups of premature babies, with parallel groups, double-blind, randomized, phase 2 on 80 eyes. Randomization is done using block randomization.
Settings and conduct
A study at Poostchi Eye Institute (Shiraz) compared two combined IVB and laser treatments for Type 1 ROP in Zone II premature infants. Patients will be randomized by block randomization method into two groups, and randomization will be performed by an assistant who had no role in treating the patients.
Participants/Inclusion and exclusion criteria
Neonates with retinopathy of prematurity (ROP) criteria will be evaluated and those who have Type ۱ ROP in Zone II were incorporated in the study
Intervention groups
Two combined IVB and laser treatments for Type 1 ROP will be compared. Group one will receive posterior dense laser (0.5 spot interval) and anterior less dense laser (1 spot interval). Group two had posterior less dense laser (1 spot interval) and anterior dense laser (0.5 spot interval). Bevacizumab will be injected, and laser photocoagulation will be performed.
Main outcome variables
Retreatment, regression time of plus disease and regression time of neovascularization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201120049450N5
Registration date:2024-07-23, 1403/05/02
Registration timing:registered_while_recruiting
Last update:2024-07-23, 1403/05/02
Update count:0
Registration date
2024-07-23, 1403/05/02
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
2024-06-30, 1403/04/10
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of combined less dense laser and bevacizumab treatment of prethreshold ROP type 1 zone 2 (stair method):a randomized controlled trial
Public title
Comparison of Two Methods of Combined Less Dense Laser and Bevacizumab Treatment of Pre threshold ROP Type 1 Zone 2 (Stair Method)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 ROP in Zone II will be incorporated in the study
Exclusion criteria:
Neonates with ROP criteria who were not in the Type 1 ROP in Zone II group were not included in the study
Threshold ROP
ROP stage 4–5
Vitreous hemorrhage
Neovascularization of iris
Aggressive posterior ROP
Elevated ridge
Age
From 1 month old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients eyes will be randomized by block randomization method into group ۱ and ۲. One eye of each patient will be included in one group and the other eye will be included in the other group. Randomization will be performed by an assistant who has no role in treating the patients. Patients and Vitreoretinal fellowship who will exam the patients before and after treatment will be blinded.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double blinded. Randomization will be done by an assistant who had no role in treating the patients. Patients and Vitreoretinal fellowship who will exam the patients before and after treatment will be blinded.
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
Zand street
City
Shiraz
Province
Fars
Postal code
7193636981
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.SUMS.REC.1402.387
Health conditions studied
1
Description of health condition studied
Retinal disorders
ICD-10 code
H35
ICD-10 code description
Other retinal disorders
Primary outcomes
1
Description
A study on premature infants compared two combined IVB and laser treatments for Type 1 ROP, evaluating outcomes (Regression of neovascularization and plus disease) and complications (cataract, vitreous hemorrhage and ...)
Timepoint
Weekly, biweekly, and bimonthly follow-ups.
Method of measurement
Regression time and complications will be evaluated.
Secondary outcomes
1
Description
Refractive errors
Timepoint
6 months old
Method of measurement
Retinoscopy
Intervention groups
1
Description
Intervention group: Two IVB and laser treatments for ROP will be compared: Group 1 has posterior dense laser (0.5 interval) and anterior less dense (1 interval), while Group 2 has posterior less dense (1 interval) and anterior dense (0.5 interval). Bevacizumab will be injected, and 360° laser photocoagulation will be performed under general anesthesia.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz university of medical science
Full name of responsible person
Ehsan namvar
Street address
Khalili hospital, khalili, shiraz, fars, iran
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
namvar_e@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
MohammadHashem Hashempour
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3235 7282
Email
namvar_e@sumsc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz university of medical sciences
Proportion provided by this source
20
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
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital, khalili, shiraz, fars, iran
City
shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
namvar_e@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital, khalili, shiraz, fars, iran
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
namvar_e@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Valiasr street
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3627 4088
Fax
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
Comparison of Two Methods of Combined Less Dense Laser and Bevacizumab Treatment of Prethreshold ROP Type ۱ Zone ۲ (Stair Method): A Randomized Controlled Trial
When the data will become available and for how long
6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
References or meta-analysis
From where data/document is obtainable
namvar.e@gmail.com
What processes are involved for a request to access data/document