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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin drops | Active Comparator | Eyes receiving eye drops containing human insulin 1U/mL |
|
| Placebo | Placebo Comparator | Eyes only receiving artificial tears |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin eye drops | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal epithelial healing | Corneal epithelial defect will be measured ar Day 2 and Day 4 using slit images. | From enrollement to day 4 post PRK |
| Measure | Description | Time Frame |
|---|---|---|
| Pain/discomfort | Subjective patient paint/discomfort scores will be recorded and compared ar day 2 and day 4 | day 4 post PRK |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elie Raad, MD | Contact | 96171092022 | eliejraad@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu de France hospital | Beirut | 166830 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fernandez, MD Alvarado, et al. "3PC-066 Compounding an eye drop formulation of topical insulin for corneal defects refractory to previous treatment: experience in real clinical practice | ||
| 33156748 | Background | Serrano-Gimenez R, Contreras-Macias E, Garcia-Bernal A, Fobelo-Lozano MJ. Insulin eye drops for treating corneal ulcer in a non-diabetic patient: regarding a case. Farm Hosp. 2020 Oct 6;44(6):297-299. doi: 10.7399/fh.11521. | |
| 32951459 |
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| Artificial tears eye-drops | Drug | The other arm receiving only artificial tears |
|
| Background |
| Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21. |
| Background | Gómez, M. M., Albaladejo, P. M., Sanz, I. R., Crespo, C. B., Durán, J. P., Alemany, A. L., ... & Martí, M. C. (2022). 3PC-020 Chemical stability and physical compatibility of insulin eye drops used in clinical practice. |
| 36871851 | Background | Castro Mora MP, Palacio Varona J, Perez Riano B, Laverde Cubides C, Rey-Rodriguez DV. Effectiveness of topical insulin for the treatment of surface corneal pathologies. Arch Soc Esp Oftalmol (Engl Ed). 2023 Apr;98(4):220-232. doi: 10.1016/j.oftale.2023.03.007. Epub 2023 Mar 5. |
| 32194500 | Background | Stuard WL, Titone R, Robertson DM. The IGF/Insulin-IGFBP Axis in Corneal Development, Wound Healing, and Disease. Front Endocrinol (Lausanne). 2020 Mar 3;11:24. doi: 10.3389/fendo.2020.00024. eCollection 2020. |