NCT06956846

Efficacy of Topical Insuline in Corneal Epithelial Healing Post PRK

Efficacy of Topical Insuline Drops in Corneal Epithelial Healing Post PRK in Non Diabetic Patients: an Randomized-controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hotel Dieu de France Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Corneal Epithelial Wound Healing

Interventions

Type	Name	Description
DRUG	insulin eye drops	Use of topical insulin eye drops following a standard excimer laser photo-refractive keratecotmy in myopic/astigmatic patients, in order to examine its efficacy in promoting corneal epithelial healing and patient comfort
DRUG	Artificial tears eye-drops	The other arm receiving only artificial tears

Timeline

• Start date: 2025-04-25
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2025-05-04
• Last updated: 2025-05-04

Locations

1 site across 1 country: Lebanon