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Completed

NCT Number: NCT02348242

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

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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Key information

Conditions

Corneal Diseases Corneal Injuries Craniocerebral Trauma Eye Diseases Eye Injuries Facial Injuries Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aqueous Gel

Device

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

Other names: Dexpanthenol® 0.2%

Eyelid Occlusion Dressing

Device

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

Other names: Pro-Ophta® Dressing

Artificial Tears

Device

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

Other names: Phylarm®

Primary outcomes

  1. Incidence rate of corneal lesions (grade > 0 in the Mercieca classification)

    Time frame: participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: OCUREA2

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2015
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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