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

NCT02348242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-02-13

No results posted yet for this study

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.

Conditions

  • Corneal Diseases

Interventions

DEVICE

Aqueous Gel

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

DEVICE

Eyelid Occlusion Dressing

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

DEVICE

Artificial Tears

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

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Jean-Michel DEVYS, Dr · Fondation Ophtalomologique Adolphe de Rothschild

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02348242 on ClinicalTrials.gov