Back to resultsOcular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches (OCUREA2)
Primary Purpose
Corneal Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aqueous Gel
Eyelid Occlusion Dressing
Artificial Tears
Sponsored by
About this trial
This is an interventional prevention trial for Corneal Diseases focused on measuring Intensive care, corneal damage, prevention, nursing protocol
Eligibility Criteria
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
Sites / Locations
- Fondation ophtalmologique Adolphe de Rothschild
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Aqueous gel
Eyelid occlusion dressing
Arm 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)
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)
Outcomes
Primary Outcome Measures
Incidence rate of corneal lesions (grade > 0 in the Mercieca classification)
Secondary Outcome Measures
Full Information
NCT ID
NCT02348242
First Posted
January 16, 2015
Last Updated
February 10, 2017
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02348242
Brief Title
Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches
Acronym
OCUREA2
Official Title
Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Diseases
Keywords
Intensive care, corneal damage, prevention, nursing protocol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aqueous gel
Arm Type
Experimental
Arm 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)
Arm Title
Eyelid occlusion dressing
Arm Type
Experimental
Arm 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)
Intervention Type
Device
Intervention Name(s)
Aqueous Gel
Other Intervention Name(s)
Dexpanthenol® 0.2%
Intervention Description
1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours
Intervention Type
Device
Intervention Name(s)
Eyelid Occlusion Dressing
Other Intervention Name(s)
Pro-Ophta® Dressing
Intervention Description
Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily
Intervention Type
Device
Intervention Name(s)
Artificial Tears
Other Intervention Name(s)
Phylarm®
Intervention Description
1 drop of Phylarm® artificial tears in the eye every 6 hours
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel DEVYS, Dr
Organizational Affiliation
Fondation Ophtalomologique Adolphe de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation ophtalmologique Adolphe de Rothschild
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches
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