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

Overview

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.

Full Title of Study: “Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2016

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

Arms, Groups and Cohorts

  • 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)
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fondation Ophtalmologique Adolphe de Rothschild
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Michel DEVYS, Dr, Principal Investigator, Fondation Ophtalomologique Adolphe de Rothschild

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