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IRCT20230510058143N1 IRCT 2023-05-16 Shahid Beheshti University of Medical Sciences Evaluation of the effect of topical erythropoietin on healing of chemical burn grade 3 and 4 clinical trial study Evaluation of the effect of topical erythropoietin on healing of chemical burn grade 3 and 4 clinical trial study 2023-05-03 anticipated 44 Complete https://irct.ir/trial/70098 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Treatment of chemical burns of the eye surface. Intervention 1: 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). Intervention 2: Control group: Patients with grade 3 and 4 corneal damage according to the Roper-Hall classification due to chemical burns, who receive standard treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Fatemeh Jafari
velenjak
Tehran Iran (Islamic Republic of) 193954631 +98 21 6694 0404 Fatima.jafari@gmail.com Shahid Beheshti University of Medical Sciences scientific Fatemeh Jafari
Velenjak
Tehran Iran (Islamic Republic of) 193954631 +98 21 6694 0404 Fatima.jafari@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both History of diabetic retinopathy Neovascular glaucoma Eye surface tumors S05.9 Unspecified injury of eye and orbit Treatment - Drugs Treatment - Drugs 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. 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. Epithelial defect. Timepoint: First day of examination, first week, first month, third and fourth. Method of measurement: Fluorescein staining by the ophthalmologist. Corneal transparency. Timepoint: First day of examination, first week, first month, third and fourth. Method of measurement: Roper-Hall classification. Best corrected visual acuity (BCVA). Timepoint: First day of examination, first week, first month, third and fourth. Method of measurement: Tumbling E-chart. Shahid Beheshti University of Medical Sciences Approved 2023-05-02 School of Medicine - Shahid Beheshti University of Medical Sciences (Ethics Committee) Volenjek Tehran Tehran Iran (Islamic Republic of)