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IRCT20250822066953N1 IRCT 2025-09-05 Bagheiat-allah University of Medical Sciences Evaluation of exosome-containing eyedrops efficacy on corneal epithelium repair after trans-PRK surgery in Baqiyatallah hospital: A randomized clinical trial Evaluation of exosome-containing eyedrops efficacy on corneal epithelium repair after trans-PRK surgery in Baqiyatallah hospital: A randomized clinical trial 2025-09-23 anticipated 20 Complete https://irct.ir/trial/85764 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For block randomization, each patient is considered as a block. For each patient, it is randomly determined which eye (right or left) will be in the test or control group. This is done by generating random numbers (e.g., a random number table). In this way, if the random number is even, the right eye will be the test and the left eye will be the control. If the random number is odd, the left eye will be the test and the right eye will be the control. A sealed envelope is prepared for each patient, inside which it is specified which eye will be in which group, Blinding description: The study is designed as a double-blind study, and the drops are pre-made by the manufacturer with a completely similar appearance and coded so that there is no difference between the exosome drops and the placebo drops, and neither the examiner nor the patient knows which eye the exosome drop was placed in and which artificial tear was placed in. 1-2 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(Exosome):Treatment: Topical exosome eye drops derived from human umbilical cord mesenchymal stem cells (Arotamin company).Dose/Frequency: One drop every 4 hours.Notes: Provided in masked, identical vials; patients also receive standard PRK postoperative medications and bandage contact lens. Intervention 2: Control group: Treatment: Balanced Salt Solution (BSS) placebo eye drops in identical, masked vials.Dose/Frequency: One drop every 4 hours.Notes: Same routine postoperative medications and contact lens as the intervention eye. 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 Ahmad Vahidi
Baqiyatallah Hospital, Sheikh Bahaii Street, Molla Sadra Street, Vanak Square
Tehran Iran (Islamic Republic of) ۱۴۳۵۹۱۶۴۷۱ +98 21 8804 0060 ahmad_vahidi@yahoo.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 Willingness to participate in the study (informed consent) No concurrent cataract No nasolacrimal duct obstruction No eyelid margin infections (blepharitis) No pterygium or other fibrovascular ocular surface diseases No retinal diseases or glaucoma No systemic diseases interfering with corneal epithelial healing, such as diabetes or malnutrition 18 years no limit Both Failure to return for follow-up appointments after surgery Postoperative corneal surface infections such as corneal ulcers Failure to use prescribed eye drops as directed 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(Exosome):Treatment: Topical exosome eye drops derived from human umbilical cord mesenchymal stem cells (Arotamin company).Dose/Frequency: One drop every 4 hours.Notes: Provided in masked, identical vials; patients also receive standard PRK postoperative medications and bandage contact lens. Control group: Treatment: Balanced Salt Solution (BSS) placebo eye drops in identical, masked vials.Dose/Frequency: One drop every 4 hours.Notes: Same routine postoperative medications and contact lens as the intervention eye. Time to complete corneal epithelial healing. Timepoint: Postoperative days 1, 2, 5, and 7 (until complete closure). Method of measurement: Application of sterile fluorescein strip and cobalt blue illumination under slit-lamp.Measurement of defect size (length × width in mm) using slit-lamp graticule.Recording of “complete/not complete closure” and calculation of time (days) to full re-epithelialization. Early ocular surface healing and symptoms(Corneal epithelial defect size,Conjunctival injection (redness),Pain score). Timepoint: Days 1, 2, 5, and 7. Method of measurement: Fluorescein staining under slit-lamp; measurement with calibrated graticule (mm² or length × width).Standard grading based on the American Academy of Ophthalmology reference chart.Visual Analog Scale (VAS 0–10) recorded in the checklist. Corneal clarity and visual acuity. Timepoint: Months 1, 3, and 6. Method of measurement: Standard slit-lamp haze grading; documented in questionnaire.Snellen or LogMAR chart. Dry eye assessment. Timepoint: Months 1, 3, and 6. Method of measurement: Fluorescein dye instillation, cobalt blue slit-lamp; time (seconds) until first dry spot appears.Sterile strip placed in lower fornix; length of wetting (mm) after standard duration.Clinical evaluation with slit-lamp; recorded in mm. Bagheiat-allah University of Medical Sciences Approved 2025-08-05 Ethical Committee of Baqiyatullah Educational and Medical Center Baqiyatallah Hospital, Sheikh Bahaii Street, Molla Sadra Street, Vanak Square Tehran Tehran Iran (Islamic Republic of)