Efficacy of Topical Insuline in Corneal Epithelial Healing Post PRK

A prospective randomized double-blind controlled trial will be conducted. The informed consent of each patient will be obtained prior to the procedure. All patients will undergo a classic PRK procedure Patients will be instructed to use eye drops blindly in both eyes at a frequency of six times daily: * In one eye: Insulin drops formulated by combining regular human insulin with artificial tears containing polyethylene glycol (PEG 400) 0,25% at a concentration of 1 unit per milliliter. * In the other eye: Placebo drops containing only artificial tears. For the double-blind trial, two identical vials will be provided to each patient: one labeled R (for the right eye) and one labeled L (for the left eye). Using the bloc randomization method, the pharmacy will be the only entity aware of the composition of each vial, ensuring that 50% of patients use insulin drops in the right eye and 50% in the left eye. Every week the drops will be prepared one day prior to the PRK procedure and will be stored in a refrigerator, to be used within one week of their preparation date. Patients will be examined by two ophthalmology residents on days 2 and 4 post-operatively. The size of the epithelial defect in both eyes will be measured using the ImageJ software. Thus, the primary outcome of the study is the ulceration closure rate: the smaller the defect, the faster the epithelial healing is. Additionally, a comparison of subjective symptoms reported by the patient in each eye will be recorded.

NCT Number	NCT06956846
Lead Sponsor	Hotel Dieu de France Hospital
Conditions	Corneal Epithelial Wound Healing
Enrollment	100 participants
Start Date	2025-04-25
Primary Completion	2025-06 (estimated)
Study Completion	2025-07 (estimated)
Updated on ClinicalTrials.gov	2025-05-04