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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250822066953N1
Enrollment
20
Registered
2025-09-05
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Myopia. Condition 2: Hypermetropia. Condition 3: Astigmatism. Condition 4: Other specified postprocedural states. Condition 5: Unspecified disorder of refraction. Myopia Hypermetropia Astigmatism Other specified postprocedural states Unspecified disorder of refraction

Interventions

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.Note
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 via

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Vahidi

Bagheiat-allah University of Medical Sciences

ahmad_vahidi@yahoo.com+98 21 8804 0060

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026