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Efficacy of Topical Insuline in Corneal Epithelial Healing Post PRK

NCT06956846 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hotel Dieu de France Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2025-06-30
Completion
2025-07-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06956846 on ClinicalTrials.gov