Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK
NCT ID: NCT06822608
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
68 participants
INTERVENTIONAL
2025-02-28
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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. The subject will participate in 1 preoperative visit, 1 postoperatively visit and following daily visits until complete reepithelialization of both eyes or day 7 postoperatively. Researchers will compare the epithelialization between the two eyes.
TREATMENT
QUADRUPLE
Study Groups
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Fixed combination of dexpanthenol and hyaluronic acid eye drops
Subjects will receive 1 drop of a fixed combination of dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops (DexHA) hourly during the day, but at least 12 times a day, until complete reepithelialization
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)
Placebo 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
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Katsimpras Marios
Principal Investigator
Locations
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National and Kapodistrian University of Athens
Athens, Greece, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CT72975
Identifier Type: -
Identifier Source: org_study_id
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