This single-blinded, stratified, randomized clinical trial was designed to evaluate the effect of topical erythropoietin on the healing of chemical burn grades 3 and 4.
Design
A randomized, single-blinded, parallel trial
Settings and conduct
All procedures are performed by a unique glaucoma surgeon (ّF. Jafari) in labbafinejad hospital. data analyzer is blinded in this study.
Participants/Inclusion and exclusion criteria
Patients who have suffered grade 3 and 4 corneal damage (according to the Roper-Hall classification) due to chemical burns and have presented to the labbafinejad hospital in the acute stage. Patients with a history of diabetic retinopathy, neovascular glaucoma, and eye surface tumors will be excluded from the study.
Intervention groups
Intervention group: Patients with grade 3 and 4 corneal damage according to the Roper-Hall classification due to chemical burns, in addition to standard medications, also use erythropoietin eye drops (3000 units/cc every 6 hours).
Control group: Patients with grade 3 and 4 corneal damage according to the Roper-Hall classification due to chemical burns, who receive standard treatment.
Evaluation of the effect of topical erythropoietin on healing of chemical burn grade 3 and 4 clinical trial study
Public title
Evaluation of the effect of topical erythropoietin on healing of chemical burn grade 3 and 4 clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have suffered grade 3 and 4 corneal damage (according to the Roper-Hall classification) due to chemical burns and have presented to thelabbafinezhad hospital in the acute stage
Exclusion criteria:
History of diabetic retinopathy
Neovascular glaucoma
Eye surface tumors
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization will be used. Participants are divided into two parallel groups of intervention ( patients in the intervention group, receiving erythropoietin eye drops) and the control group (the group that receives routine treatment) by using (block size = 4) random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present clinical trial the surgeon and patients will be aware of the classification groups (Intervention and control) and only the biostatistician who analyzed the data are blinded to label assignment of patients to each of 2 arms of the study protocol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine - Shahid Beheshti University of Medical Sciences (Ethics Committee)
Street address
Volenjek
City
Tehran
Province
Tehran
Postal code
193954631
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.SBMU.MSP.REC.1402.046
Health conditions studied
1
Description of health condition studied
Treatment of chemical burns of the eye surface
ICD-10 code
S05.9
ICD-10 code description
Unspecified injury of eye and orbit
Primary outcomes
1
Description
Avascular lesions
Timepoint
First day of examination, first week, first month, third and fourth
Method of measurement
by PhotoSlit and and with the help of Image J software by an operator
2
Description
Epithelial defect
Timepoint
First day of examination, first week, first month, third and fourth
Method of measurement
Fluorescein staining by the ophthalmologist
3
Description
Corneal transparency
Timepoint
First day of examination, first week, first month, third and fourth
Method of measurement
Roper-Hall classification
Secondary outcomes
1
Description
Best corrected visual acuity (BCVA)
Timepoint
First day of examination, first week, first month, third and fourth
Method of measurement
Tumbling E-chart
Intervention groups
1
Description
Intervention group: Patients with grade 3 and 4 corneal damage according to the Roper-Hall classification due to chemical burns, in addition to standard medications, also use erythropoietin eye drops (3000 units/cc every 6 hours).
Category
Treatment - Drugs
2
Description
Control group: Patients with grade 3 and 4 corneal damage according to the Roper-Hall classification due to chemical burns, who receive standard treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
labbafinejad hospital
Full name of responsible person
Fatemeh Jafari
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 6694 0404
Email
Fatima.jafari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepehr Feizi
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 6694 0404
Email
sepehrfeizi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
velenjak
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 6694 0404
Email
Fatima.jafari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 6694 0404
Email
Fatima.jafari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 6694 0404
Email
Fatima.jafari@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