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NCT Number: NCT06956846

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Artificial tears eye-drops

Drug

The other arm receiving only artificial tears

Primary outcomes

  1. Corneal epithelial healing

    Time frame: From enrollement to day 4 post PRK

    Corneal epithelial defect will be measured ar Day 2 and Day 4 using slit images.

Secondary outcomes

  1. Pain/discomfort

    Time frame: day 4 post PRK

    Subjective patient paint/discomfort scores will be recorded and compared ar day 2 and day 4

Study contacts

Contact information is provided by the study sponsor or research team.

Elie Raad, MD

CONTACT

[email protected]

96171092022

Sponsors and collaborators

Lead sponsor

Hotel Dieu de France Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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