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IRCT20250702066328N1 IRCT 2025-12-29 Zahedan University of Medical Sciences Investigating the effectiveness of umbilical cord blood serum on curing eye dryness Investigating the effectiveness of umbilical cord blood serum on curing eye dryness 2025-12-16 anticipated 64 Complete https://irct.ir/trial/84524 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients to two groups is performed using the permuted block stratified randomization method. First, eligible patients are classified according to age and gender in the order of arrival. Then, they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two replications for each) that are randomly selected from all possible permutations. These blocks were created using R statistical software version 4.0.2. Matching: The two groups are matched in terms of age and sex using a stratified permutation block randomization method (frequency matching). Blinding: This study uses a single blinding method, so that the technician responsible for recording the outcomes will not be aware of the intervention in question, Blinding description: This study uses a single blinding method, so that the technician responsible for recording the outcomes will not be aware of the intervention in question. 3 Dry eye. Intervention 1: Intervention Group:Patients in this group will receive eye drops prepared from diluted human umbilical cord blood serum in combination with standard artificial tears. The cord blood serum is diluted to a specific concentration and prepared under sterile conditions. Patients will instill one drop in each eye four times daily. The treatment duration is 6 months, with regular follow-up visits to assess the effect on visual acuity, dry eye questionnaire score, corneal sensitivity, tear breakup time, extent of corneal staining, tear meniscus height, and blink rate. Intervention 2: Control group: Patients in this group will receive only standard artificial tears, instilled one drop in each eye four times daily. The follow-up schedule and assessment parameters are the same as in the intervention group. Yes - There is a plan to make this available What will be shared: Some of the information related to the main outcome, such as age, gender, and level of education, will be shared temporarily. When: Access period begins after results are printed. To whom: Researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions Where to obtain: email:mehranejafarimums@gmail.com How to obtain: Providing job information, educational qualifications, and the reason for requesting the file Comments:
public Mehraneh Jafari
Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran
Zahedan Iran (Islamic Republic of) 9816737791 54333372113 Mehranejafarimums@gmail.com Zahedan University of Medical Sciences scientific Mohammadhossein Validad
Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran
Zahedan Iran (Islamic Republic of) 9816737791 +98 54 3337 2113 Mhovalidad@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Patients with dry eyes for more than 3 months that do not improve with conventional treatment (such as artificial tears or ointments) Patients with dry eye who have a Type I Schirmer test of less than 5 mm Dry eye patients with Oxford test scores greater than stage 3 18 years no limit Both Age under 18 years Pregnancy Use of contact lenses History of ocular allergy, intraocular surgery, and/or refractive surgery within the past 6 months Anatomical changes of the eyelids and/or eyelashes Patients with infectious or transmissible diseases such as HBV, HCV, or HIV H04 Disorders of lacrimal system Treatment - Drugs Treatment - Drugs Intervention Group:Patients in this group will receive eye drops prepared from diluted human umbilical cord blood serum in combination with standard artificial tears. The cord blood serum is diluted to a specific concentration and prepared under sterile conditions. Patients will instill one drop in each eye four times daily. The treatment duration is 6 months, with regular follow-up visits to assess the effect on visual acuity, dry eye questionnaire score, corneal sensitivity, tear breakup time, extent of corneal staining, tear meniscus height, and blink rate. Control group: Patients in this group will receive only standard artificial tears, instilled one drop in each eye four times daily. The follow-up schedule and assessment parameters are the same as in the intervention group. Determining and comparing average visual acuity in dry eye treatment. Timepoint: At the beginning of the study and the first and third months after the start of the diluted fetal umbilical cord blood serum drip. Method of measurement: It was measured based on the LogMAR method (Logarithm of the minimum angle of resolution). Determining and comparing the average dryness score in dry eye treatment. Timepoint: At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum. Method of measurement: It is determined based on the OSDI questionnaire score and recorded in the information form. Corneal sensitivity. Timepoint: ‏At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum. Method of measurement: Corneal sensitivity. Tear film break up time. Timepoint: ‏At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum. Method of measurement: tear film breakup time (Second). The height of the lacrimal prism. Timepoint: ‏At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum. Method of measurement: Tear meniscus height is measured using slit lamp examination and recorded on the information form. Blink frequency. Timepoint: ‏At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum. Method of measurement: It is determined based on blink rates (25%, 50%, 75% blinks, All lid closures, Extended lid closures, and Superextended lid closures) and recorded in the information form. Zahedan University of Medical Sciences Approved 2025-04-20 Ethics Committee of Zahedan University of Medical Sciences Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)