]>
IRCT20250105064285N1 IRCT 2025-02-13 Bagheiat-allah University of Medical Sciences The effect of umbilical cord eyedrop on corneal repair ups Evaluation efficacy of umbilical cord serum eye drops on corneal epithelium repair after trans-PRK refractive surgery in Baqiyatullah Hospital 2025-04-04 anticipated 30 Complete https://irct.ir/trial/81758 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a total of 30 patients will be evaluated (one eye in the test group and the other in the control group, totaling 60 eyes). Both eyes of the patients will receive contact lenses and routine postoperative medications after PRK surgery. However, one eye will be treated with umbilical cord serum eye drops, while the other eye will receive sterile distilled water eye drops using identical vials (one drop every four hours). The selection of the eye receiving the umbilical cord serum eye drops will be determined through random allocation using a variable block method. The unit of randomization is each individual's eye, Blinding description: The drops are made by the manufacturing company in a completely similar and coded way in advance so that there is no difference between the fetal cord serum drop and the placebo drop, and neither the examiner nor the patient knows in which eye the fetal cord serum drop was put and in which sterile distilled water. 2 Condition 1: Myopia. Condition 2: Hypermetropia. Condition 3: Astigmatism. Condition 4: Other specified postprocedural states. Condition 5: Unspecified disorder of refraction. Intervention 1: Intervention Group: Eyes Receiving Umbilical Cord Blood Serum Eye DropsIn this study, one eye of each patient is randomly assigned to the intervention group and treated with Umbilical Cord Blood Serum (UCBS) Eye Drops. This treatment accelerates corneal wound healing and reduces inflammation due to the presence of growth factors, cytokines, and nutritional proteins.Equipment and ConsumablesUmbilical Cord Blood Serum (UCBS):Derived from freshly collected umbilical cord blood samples.After screening for infectious diseases, the blood is centrifuged to separate plasma.Preparation Process:The serum is stored under sterile conditions at -80°C and brought to 4°C before use.Chemical Composition:Contains growth factors (EGF, TGF-β, PDGF, VEGF), albumin, immunoglobulins, and vitamin A.Concentration:Typically 20% (one part serum diluted in four parts sterile saline solution).Dosage and AdministrationDosage: One drop every 4 hours in the intervention eye (6 times per day).Duration of Treatment: At least 7 days (or until complete corneal epithelial healing).Administration:Patients apply the drops in a sterile manner following PRK surgery, as per the treatment protocol.Comparison with the Control GroupThe contralateral eye (control eye) of the same patient receives sterile distilled water drops in visually identical vials to maintain a placebo effect.Manufacturer and Quality ControlProduction Site: Umbilical cord blood banks or authorized biological product laboratories.Quality Control:Sterility testing, microbial contamination checks, and verification of active components before use. Intervention 2: Control group: The eyes that will receive sterile distilled water drops. Yes - There is a plan to make this available What will be shared: Part of the data related to the results of the study will be shared for researchers to conduct future research When: One year after the results are published To whom: Researchers working in scientific and academic centers Conditions: It will be possible to access the data by specifying the source of information and preserving the intellectual rights of patients and study researchers Where to obtain: Ophthalmology Department of Baqiyatullah Hospital How to obtain: After sending an email from the researcher to correspond of the study, the goals of the researcher will be checked for access to the data, and if approved, the information will be accessible in the Department of Ophthalmology of Baqiyatullah. Comments:
public Mahmood Hassani
Vanak' molasadra 'baghiatalah hospital
Tehran Iran (Islamic Republic of) 1371737141 +98 21 6667 4267 Maha7092@gmail.com Bagheiat-allah University of Medical Sciences scientific seyed-hashem daryabari
Baqiyatallah Hospital, Sheikh Bahaii Street, Molla Sadra Street, Vanak Square
Tehran Iran (Islamic Republic of) ۱۴۳۵۹۱۶۴۷۱ +98 21 8821 0168 drdaryabari@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Indication for prk surgery Consent to participate in the study 18 years 45 years Male Failure to return for follow-up examinations after surgery H52.1 H52.0 H52.2 Z98.89 H52.7 Myopia Hypermetropia Astigmatism Other specified postprocedural states Unspecified disorder of refraction Treatment - Drugs Placebo Intervention Group: Eyes Receiving Umbilical Cord Blood Serum Eye DropsIn this study, one eye of each patient is randomly assigned to the intervention group and treated with Umbilical Cord Blood Serum (UCBS) Eye Drops. This treatment accelerates corneal wound healing and reduces inflammation due to the presence of growth factors, cytokines, and nutritional proteins.Equipment and ConsumablesUmbilical Cord Blood Serum (UCBS):Derived from freshly collected umbilical cord blood samples.After screening for infectious diseases, the blood is centrifuged to separate plasma.Preparation Process:The serum is stored under sterile conditions at -80°C and brought to 4°C before use.Chemical Composition:Contains growth factors (EGF, TGF-β, PDGF, VEGF), albumin, immunoglobulins, and vitamin A.Concentration:Typically 20% (one part serum diluted in four parts sterile saline solution).Dosage and AdministrationDosage: One drop every 4 hours in the intervention eye (6 times per day).Duration of Treatment: At least 7 days (or until complete corneal epithelial healing).Administration:Patients apply the drops in a sterile manner following PRK surgery, as per the treatment protocol.Comparison with the Control GroupThe contralateral eye (control eye) of the same patient receives sterile distilled water drops in visually identical vials to maintain a placebo effect.Manufacturer and Quality ControlProduction Site: Umbilical cord blood banks or authorized biological product laboratories.Quality Control:Sterility testing, microbial contamination checks, and verification of active components before use. Control group: The eyes that will receive sterile distilled water drops. Improvement in corneal epithelial defects. Timepoint: on the first, second, fifth, and seventh days post-surgery. Method of measurement: By measuring the extent and size of the defect. Pain levels. Timepoint: on the first, second, fifth, and seventh days post-surgery. Method of measurement: Through the patient's own assessment of pain intensity based on a score of 1-10. Corneal Haziness. Timepoint: In the first, third, sixth month. Method of measurement: Through slit lamp examination. Best corrected visual aquity. Timepoint: In the first, third, sixth month. Method of measurement: Snellen chart. Dry eye tests. Timepoint: In the first, third, sixth month. Method of measurement: TBUT, Strip Test, Tear High. Confocal paraclinical test results. Timepoint: six months after surgery. Method of measurement: printout report. Bagheiat-allah University of Medical Sciences Approved 2024-08-10 Ethical Committee of Baqiyatullah Educational and Medical Center Baqiyatallah Hospital, Sheikh Bahaii Street, Molla Sadra Street, Vanak Square Tehran Tehran Iran (Islamic Republic of)