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

Not Applicable

Completed

• Conditions: Corneal Diseases
• Interventions: Device: Eyelid Occlusion Dressing; Device: Aqueous Gel; Device: Artificial Tears

• Registration Number: NCT02348242
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eyelid occlusion dressing	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)
Aqueous gel	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)
Aqueous gel	Artificial Tears	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	Artificial Tears	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)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fondation ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, Ile-de-France, France