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
About this trial
This is an interventional prevention trial for Keratitis focused on measuring keratopathy, exposure, intensive care, eye, ulcer, Corneal
Eligibility Criteria
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
NCT ID
NCT00513734
First Posted
August 8, 2007
Last Updated
August 8, 2007
Sponsor
Barts & The London NHS Trust
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
We'll reach out to this number within 24 hrs