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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed combination of dexpanthenol and hyaluronic acid eye drops | Active Comparator | 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 |
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| Placebo eye drops | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reepithelialization. | The primary endpoint is the time to reepithelialization. Slitlamp biomicroscopy will be preformed to evaluate the integrity of the corneal media and objectively assess epithelial healing with the use of fluoroscein staining. Α record of the time needed until no staining is present will be made. | From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Epithelial defect size in each visit | Epithelial defect size at each visit measured by slitlamp biomicroscopy The integrity of the corneal media is calculated from the remaining area (A) of the epithelial defects using the following equation: A=π {(α +b) /4}2 where a is the shortest dimension of the defect and b is the longest dimension. | From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marios P Katsimpras, MD, MSc, PhDc | Contact | +306970504810 | katsimpras_marios@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National and Kapodistrian University of Athens | Athens | Greece | 11527 | Greece |
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This is a contralateral, randomized, double-blind, placebo-controlled (HA) trial.
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.
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| Placebo | Drug | 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) |
|
| Subjective evaluation of pain (discomfort) | Pain scores will be evaluated using a questionnaire on a scale of 0 to 4 as follows:
| From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively. |
| Subjective evaluation of vision | Uncorrected distance visual acuity measured using logMAR ETDRS charts at 4 m | From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively. |
| ID | Term |
|---|---|
| C007288 | dexpanthenol |
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