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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-02-29

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.

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Detailed Description

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Conditions

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Corneal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aqueous gel

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)

Group Type EXPERIMENTAL

Aqueous Gel

Intervention Type DEVICE

1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours

Artificial Tears

Intervention Type DEVICE

1 drop of Phylarm® artificial tears in the eye every 6 hours

Eyelid occlusion dressing

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)

Group Type EXPERIMENTAL

Eyelid Occlusion Dressing

Intervention Type DEVICE

Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily

Artificial Tears

Intervention Type DEVICE

1 drop of Phylarm® artificial tears in the eye every 6 hours

Interventions

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Aqueous Gel

1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours

Intervention Type DEVICE

Eyelid Occlusion Dressing

Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily

Intervention Type DEVICE

Artificial Tears

1 drop of Phylarm® artificial tears in the eye every 6 hours

Intervention Type DEVICE

Other Intervention Names

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Dexpanthenol® 0.2% Pro-Ophta® Dressing Phylarm®

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