Corneal Epithelial Wound Healing
Conditions
Brief 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.
Interventions
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
The other arm receiving only artificial tears
Sponsors
Hotel Dieu de France Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Myopic or astigmatic patient undergoing excimer laser PRK
Exclusion criteria
* diabetes mellitus prior ocular surgery ocular surface disease (including dry eye disease, history of herpetic keratitis) previous ocular trauma use of systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal epithelial healing | From enrollement to day 4 post PRK | Corneal epithelial defect will be measured ar Day 2 and Day 4 using slit images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain/discomfort | day 4 post PRK | Subjective patient paint/discomfort scores will be recorded and compared ar day 2 and day 4 |
Countries
Lebanon
Contacts
Primary ContactElie Raad, MD
Outcome results
None listed