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

February 10, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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: Artificial Tears
1 drop of Phylarm® artificial tears in the eye every 6 hours
Other Names:
  • Phylarm®
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Jean-Michel DEVYS, Dr, Fondation Ophtalomologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (ESTIMATE)

January 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01197-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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