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

NCT ID: NCT00513734

Last Updated: 2007-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Study Groups

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1

Geliperm Hydrogel Dressing

Group Type ACTIVE_COMPARATOR

Hydrogel dressing

Intervention Type OTHER

3x3cm hydrogel dressing over closed eye

2

Lacrilube ointment

Group Type ACTIVE_COMPARATOR

Lacrilube ointment

Intervention Type OTHER

lubricant put into eye (inferior formix)

Interventions

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Hydrogel dressing

3x3cm hydrogel dressing over closed eye

Intervention Type OTHER

Lacrilube ointment

lubricant put into eye (inferior formix)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Primary orbital injury
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barts & The London NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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Marie Healy, FRCA

Role: STUDY_DIRECTOR

Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB

Other Identifiers

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003171

Identifier Type: -

Identifier Source: org_study_id