Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens

About this trial

The aim of this prospective, contralateral, randomized, double-blind, placebo-controlled study is the evaluation of the performance of a fixed combination of dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops, in corneal wound healing after trans epithelial photorefractive keratectomy. One eye of each patient, randomly determined, will be assigned to receive artificial tears containing a combination of dexpanthenol-hyaluronic acid (study group) while the fellow eye will receive Placebo / identical combination containing the same ingredients and hyaluronic acid without dexpanthenol (control group). The drops will be applied hourly postoperatively, starting one hour after the surgery. All subjects will be treated until the day of complete reepithelialization or a maximum of 7 days postoperatively. Researchers will compare the epithelialization between the two eyes. The primary endpoint is the time to reepithelialization.The secondary endpoints are the intra-individual differences measured in each eye in terms of epithelial defect size in each visit, subjective evaluation of pain (discomfort) and subjective evaluation of vision.

Eligibility criteria

Qualifiers

Male and female subjects aged ≥ 18

Bilateral trans PRK for the correction of myopia using the Schwind Amaris 1050RS laser at the same treatment zone (6.5mm)

Signed written informed consent Ability and willingness to participate in all examinations

Disqualifiers

Known hypersensitivity or intolerance to any component of the product

Previous refractive surgery

Myopic refractive error higher than 8.00 diopters (D)

Anisometropia higher than 2.00 D

Trial design

Treatments tested in this trial

  • dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops
  • Placebo

Treatment groups

68 Participants
are divided into 2 treatment groups