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Not yet recruiting NCT06956846

Efficacy of Topical Insuline in Corneal Epithelial Healing Post PRK

Phase IV Interventional Corneal Epithelial Wound Healing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: insulin eye drops, Artificial tears eye-drops.
Who it may be relevant to
Registry conditions: Corneal Epithelial Wound Healing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Lebanon
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

  • Corneal epithelial healing [Time frame: From enrollement to day 4 post PRK]
Secondary outcome measures (1)
  • Pain/discomfort [Time frame: day 4 post PRK]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Triple blind
Primary purpose
Treatment

Study locations

Lebanon · 1 center
  • Hotel Dieu de France hospital — Beirut

Publications

  • 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
  • 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. PMID 33156748
  • 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. PMID 32951459
  • 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.
  • 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. PMID 36871851
  • 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. PMID 32194500

Identifiers

NCT: NCT06956846 · CEHDF2402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗