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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Corneal Diseases

Treatments: Device: Artificial Tears; Device: Eyelid Occlusion Dressing; Device: Aqueous Gel

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02348242

2014-A01197-40

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Aqueous gel

Experimental group

Description:

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)

Treatment:

Device: Aqueous Gel

Device: Artificial Tears

Eyelid occlusion dressing

Experimental group

Description:

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)

Treatment:

Device: Eyelid Occlusion Dressing

Device: Artificial Tears