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

Keratitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513734
• Other study ID #: 003171
• Status: Completed
• Phase: N/A
• First received: August 8, 2007
• Last updated: August 8, 2007
• Start date: September 2004
• Est. completion date: February 2005

Study information

• Verified date: August 2007
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Primary orbital injury

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Keratitis

Intervention

Other:
• Hydrogel dressing
3x3cm hydrogel dressing over closed eye
• Lacrilube ointment
lubricant put into eye (inferior formix)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of clinically significant corneal exposure		throughout length of admission to ITU