Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches

Study Overview
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Brief Summary
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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.

Official Title
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Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study

Conditions
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Corneal Diseases

Intervention / Treatment
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* Device: Aqueous Gel
* Device: Eyelid Occlusion Dressing
* Device: Artificial Tears


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patient hospitalized in an intensive care unit tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h Exclusion Criteria: Patient currently treated by eyedrops for glaucoma antecedent of corneal transplant ocular prosthesis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aqueous gel<br>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) | Device: Aqueous Gel<br>* 1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours<br>* Other names: Dexpanthenol® 0.2%;Device: Artificial Tears<br>* 1 drop of Phylarm® artificial tears in the eye every 6 hours<br>* Other names: Phylarm®;|
| Experimental: Eyelid occlusion dressing<br>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) | Device: Eyelid Occlusion Dressing<br>* Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily<br>* Other names: Pro-Ophta® Dressing;Device: Artificial Tears<br>* 1 drop of Phylarm® artificial tears in the eye every 6 hours<br>* Other names: Phylarm®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care, corneal damage, prevention, nursing protocol