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

• Sponsor: Barts & The London NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT00513734
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Months): 5

Study Details

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	Phase
Keratitis	Other: Hydrogel dressing; Other: Lacrilube ointment	N/A

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
• 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: Sep 1, 2004
• Actual Study Completion Date: Feb 1, 2005

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 [throughout length of admission to ITU]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00513734
• Other Study ID Numbers: 003171
• First Posted: Aug 9, 2007
• Last Update Posted: Aug 9, 2007
• Last Verified: Aug 1, 2007

• Keywords provided by , ,: keratopathy; exposure; intensive care; eye; ulcer; Corneal
• Additional relevant MeSH terms: Keratitis

Study Results

No Results Posted as of Aug 9, 2007