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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02348242
Acronym
OCUREA2
Enrollment
49
Registered
2015-01-28
Start date
2014-12-31
Completion date
2016-02-29
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Diseases

Keywords

Intensive care, corneal damage, prevention, nursing protocol

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.

Interventions

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

DEVICEEyelid Occlusion Dressing

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

DEVICEArtificial Tears

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

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Exclusion criteria

* Patient currently treated by eyedrops for glaucoma * antecedent of corneal transplant * ocular prosthesis

Design outcomes

Primary

MeasureTime 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026