OCUREA2: Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT02348242

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Diseases	Device: Aqueous Gel Device: Eyelid Occlusion Dressing Device: Artificial Tears	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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)

Device: Aqueous Gel

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

Other Names:

Dexpanthenol® 0.2%

Device: Artificial Tears

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

Other Names:

Phylarm®

Experimental: 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)

Device: Eyelid Occlusion Dressing

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

Other Names:

Pro-Ophta® Dressing

Device: Artificial Tears

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

Other Names:

Phylarm®

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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