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

This study has been completed.
Sponsor:
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00513734
First received: August 8, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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 Intervention
Keratitis
 Other: Hydrogel dressing
Other: Lacrilube ointment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barts & The London NHS Trust:

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

Enrollment: 40
Study Start Date: September 2004
Study Completion Date: February 2005
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00513734     History of Changes
Other Study ID Numbers: 003171
Study First Received: August 8, 2007
Last Updated: August 8, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 23, 2013