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

Sponsored by:	Barts & The London NHS Trust
Information provided by:	Barts & The London NHS Trust
ClinicalTrials.gov Identifier:	NCT00513734

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Active Comparator Geliperm Hydrogel Dressing	Other: Hydrogel dressing 3x3cm hydrogel dressing over closed eye
2: Active Comparator 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

Study ID Numbers:	003171
Study First Received:	August 8, 2007
Last Updated:	August 8, 2007
ClinicalTrials.gov Identifier:	NCT00513734
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

Study placed in the following topic categories:

Corneal Diseases
Critical Illness
Eye Diseases
Ulcer
Keratitis

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009