Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK
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: dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops, Placebo.
- 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
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Fixed Combination of Dexpanthenol and Hyaluronic Acid Preservative-free Eye Drops on Corneal Epithelialization After Trans Epithelial PRK: a Prospective, Contralateral, Randomized, Double-blind, Placebo-controlled Trial
Overview
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.
Interventions
- Drug dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops
Subjects will receive 1 drop of a hyaluronic acid preservative-free eye artificial tears eye drops (HA) as PLACEBO hourly during the day, but at least 12 times a day, until complete reepithelialization. Composition: 1 ml contains Sodium Hyaluronate 0.15 %, Sodium Chloride, Sodium Citrate, Citric Acid, Water for Injections Dosage Form: Single-dose container (0.5 mL) - Drug Placebo
Subjects will receive 1 drop of a hyaluronic acid preservative-free eye artificial tears eye drops (HA) as PLACEBO hourly during the day, but at least 12 times a day, until complete reepithelialization. Composition: 1 ml contains Sodium Hyaluronate 0.15 %, Sodium Chloride, Sodium Citrate, Citric Acid, Water for Injections Dosage Form: Single-dose container (0.5 mL)
Primary outcome measures
- Time to reepithelialization. [Time frame: From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.]
Secondary outcome measures (3)
- Epithelial defect size in each visit [Time frame: From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.]
- Subjective evaluation of pain (discomfort) [Time frame: From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.]
- Subjective evaluation of vision [Time frame: From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Ocular or systemic disease that could affect epithelial healing
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Greece · 1 center
- National and Kapodistrian University of Athens — Athens
Identifiers
NCT: NCT06822608 · CT72975