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IRCT20240706062337N3 IRCT 2026-10-05 Shiraz University of Medical Sciences Effect of Platelet-Rich Plasma-Derived Exosome Eye Drops in the Treatment of Dry Eye and Persistent Corneal Defects Studying the effect of platelet-rich plasma-derived exosome (PRP-Exosome) on the treatment of dry eye and persistent corneal defects- Interventional - before and after 2027-03-06 anticipated 50 Pending https://irct.ir/trial/93377 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Condition 1: Dry eye disease. Condition 2: Corneal epithelial defect. Intervention group: Intervention group: Autologous platelet-rich plasma (PRP) derived exosome eye drops. Peripheral blood is obtained from the patient, and exosomes are extracted via centrifugation and platelet lysis protocols, followed by 0.22 micrometer sterile filtration. The exosomes are diluted to a 20% volume per volume concentration in an artificial tears. Patients administer 1 drop into the affected eye four times daily (every 6 hours) for 28 consecutive days.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the fact that I have not yet consulted with the colleagues participating in the project, therefore I have not specified the relevant program.
public Fatemeh Sanie-Jahromi
Zand Boulevard, Asadabadi Street, Poostchi Ophthalmology Research Center
Shiraz Iran (Islamic Republic of) 7134997446 +98 71 3230 2830 fsanie@sums.ac.ir Shiraz University of Medical Sciences scientific Fatemeh Sanie-Jahromi
Zand Boulevard, Poostchi Street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134997446 +98 71 3230 2830 fsanie@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 18 years or older. Clinical diagnosis of persistent corneal epithelial defect (lack of significant epithelial healing for 2 weeks or more despite standard supportive treatments) and/or dry eye-related epithelial lesions confirmed by an ophthalmologist. Ability and willingness to comply with all study follow-up visits on days 0, 7, 14, and 28. Provision of written informed consent after receiving comprehensive information regarding the study objectives, procedures, potential benefits, and risks. 18 years no limit Both Active ocular infection (corneal or conjunctival infection with purulent discharge) requiring immediate systemic or intensive topical antimicrobial therapy. Known history of hypersensitivity or anaphylactic reaction to blood products or preservatives used in the artificial tears. Pregnancy or breastfeeding. Concurrent use of topical or systemic medications that substantially interfere with corneal epithelial wound healing and cannot be safely discontinued (e.g., high-dose systemic corticosteroids or potent immunosuppressive agents). Severe uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus or end-stage renal/hepatic failure) that may compromise patient safety or treatment response. Baseline hematological abnormalities or markedly low platelet counts that preclude the preparation of adequate-quality autologous platelet-rich plasma (PRP). Concurrent participation in any other clinical trial that could interfere with the study interventions or outcomes. H04.129 H59 Dry eye syndrome of unspecified lacrimal gland Intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified Treatment - Other Intervention group: Intervention group: Autologous platelet-rich plasma (PRP) derived exosome eye drops. Peripheral blood is obtained from the patient, and exosomes are extracted via centrifugation and platelet lysis protocols, followed by 0.22 micrometer sterile filtration. The exosomes are diluted to a 20% volume per volume concentration in an artificial tears. Patients administer 1 drop into the affected eye four times daily (every 6 hours) for 28 consecutive days. Complete healing of the persistent corneal epithelial defect, defined as total re-epithelialization with negative corneal fluorescein staining. Timepoint: Before intervention (day 0) and days 7, 14, and 28 after intervention. Method of measurement: Slit lamp biomicroscopy examination combined with cobalt blue light digital photography following one percent sodium fluorescein eye drop instillation, and calculation of the defect area in square millimeters using digital image analysis software. Improvement in dry eye disease severity based on tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI) score. Timepoint: Before intervention (day 0) and days 7, 14, and 28 after intervention. Method of measurement: Measurement of tear break up time in seconds using slit lamp biomicroscopy with cobalt blue illumination following instillation of sodium fluorescein solution. Shiraz University of Medical Sciences Approved 2026-07-29 Ethics committee of Shiraz University of Medical Sciences Zand Boulevard, Poostchi Street, Poostchi Ophthalmology Research Center Shiraz Fars Iran (Islamic Republic of)