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A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill

Primary Purpose

Keratitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydrogel dressing
Lacrilube ointment
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keratitis focused on measuring keratopathy, exposure, intensive care, eye, ulcer, Corneal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients admitted to Intensive care and expected to stay for more than 2 days

Exclusion Criteria:

  • Primary orbital injury

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Geliperm Hydrogel Dressing

    Lacrilube ointment

    Outcomes

    Primary Outcome Measures

    Development of clinically significant corneal exposure

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2007
    Last Updated
    August 8, 2007
    Sponsor
    Barts & The London NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00513734
    Brief Title
    A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill
    Official Title
    Randomised Trial Comparing the Efficacy of Ocular Lubricant (Lacrilube) and Polyacrylamide Hydrogel Dressing (Geliperm) for the Prevention of Exposure Keratopathy in the Critically Ill
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Barts & The London NHS Trust

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Corneal damage in critically ill patients is common. There are currently two popular methods of treatment in the UK; hydrogel dressings and lubricating ointment. We propose to randomise patients to have a different treatment for each eye and see which one is more effective.
    Detailed Description
    Microbial keratitis, particularly pseudomonas-related, has been widely reported amongst Intensive therapy unit (ITU) patients and the need for effective eye care in ITU has been recognised for some time. We compare two popular methods of eye care; a hydrogel dressing and lacrilube ointment. Each recruited patient had each eye randomised to different treatments. Daily ophthalmology ward rounds were undertaken to identify any corneal exposure keratopathy. Patients were removed from the trial if one eye developed significant exposure needing treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratitis
    Keywords
    keratopathy, exposure, intensive care, eye, ulcer, Corneal

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Geliperm Hydrogel Dressing
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Lacrilube ointment
    Intervention Type
    Other
    Intervention Name(s)
    Hydrogel dressing
    Intervention Description
    3x3cm hydrogel dressing over closed eye
    Intervention Type
    Other
    Intervention Name(s)
    Lacrilube ointment
    Intervention Description
    lubricant put into eye (inferior formix)
    Primary Outcome Measure Information:
    Title
    Development of clinically significant corneal exposure
    Time Frame
    throughout length of admission to ITU

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients admitted to Intensive care and expected to stay for more than 2 days Exclusion Criteria: Primary orbital injury
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marie Healy, FRCA
    Organizational Affiliation
    Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill

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