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60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). The prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never been compared in a rigorous study. Therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients.
This study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aqueous gel | Experimental | In the same patient : one eye receives regular administration of aqueous gel (experimental treatment 1) and the other eye receives regular administration of artificial tears (active comparator) |
|
| Eyelid occlusion dressing | Experimental | In the same patient : one eye is closed with an eyelid closure dressing (experimental treatment 2) and the other eye receives regular administration of artificial tears (active comparator) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aqueous Gel | Device | 1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of corneal lesions (grade > 0 in the Mercieca classification) | participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel DEVYS, Dr | Fondation Ophtalomologique Adolphe de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation ophtalmologique Adolphe de Rothschild | Paris | Île-de-France Region | 75019 | France |
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D065306 | Corneal Injuries |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005131 | Eye Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| Eyelid Occlusion Dressing | Device | Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily |
|
|
| Artificial Tears | Device | 1 drop of Phylarm® artificial tears in the eye every 6 hours |
|
|
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |