Health TrialsbyHealthPanel

Efficacy of Topical Insuline in Corneal Epithelial Healing Post PRK

ConditionCorneal Epithelial Wound Healing
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHotel Dieu de France Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Myopic or astigmatic patient undergoing excimer laser PRK

Disqualifiers

diabetes mellitus prior ocular surgery ocular surface disease (including dry eye disease, history of herpetic keratitis) previous ocular trauma use of systemic corticosteroids

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Insulin dropsActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Corneal epithelial healing

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

Time frame
From enrollement to day 4 post PRK

Secondary outcomes

1

Pain/discomfort

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

Time frame
day 4 post PRK

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hotel Dieu de France Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: