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

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ClinicalTrials.gov Identifier: NCT00513734
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : August 9, 2007
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Keratitis Other: Hydrogel dressing Other: Lacrilube ointment

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
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 Start Date : September 2004
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Geliperm Hydrogel Dressing
Other: Hydrogel dressing
3x3cm hydrogel dressing over closed eye
Active Comparator: 2
Lacrilube ointment
Other: Lacrilube ointment
lubricant put into eye (inferior formix)


Outcome Measures

Primary Outcome Measures :
  1. Development of clinically significant corneal exposure [ Time Frame: throughout length of admission to ITU ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Primary orbital injury
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513734


Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Study Director: Marie Healy, FRCA Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB
More Information

ClinicalTrials.gov Identifier: NCT00513734     History of Changes
Other Study ID Numbers: 003171
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: August 9, 2007
Last Verified: August 2007

Keywords provided by Barts & The London NHS Trust:
keratopathy
exposure
intensive care
eye
ulcer
Corneal

Additional relevant MeSH terms:
Critical Illness
Keratitis
Disease Attributes
Pathologic Processes
Corneal Diseases
Eye Diseases