Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-13 @ 1:03 PM
Study NCT ID:
NCT00513734
Status:
COMPLETED
Last Update Posted:
2007-08-09
First Post:
2007-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D014456', 'term': 'Ulcer'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047070', 'term': 'Bandages, Hydrocolloid'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-08', 'studyFirstSubmitDate': '2007-08-08', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of clinically significant corneal exposure', 'timeFrame': 'throughout length of admission to ITU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['keratopathy', 'exposure', 'intensive care', 'eye', 'ulcer', 'Corneal'], 'conditions': ['Keratitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to Intensive care and expected to stay for more than 2 days\n\nExclusion Criteria:\n\n* Primary orbital injury'}, 'identificationModule': {'nctId': 'NCT00513734', 'briefTitle': 'A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Randomised Trial Comparing the Efficacy of Ocular Lubricant (Lacrilube) and Polyacrylamide Hydrogel Dressing (Geliperm) for the Prevention of Exposure Keratopathy in the Critically Ill', 'orgStudyIdInfo': {'id': '003171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Geliperm Hydrogel Dressing', 'interventionNames': ['Other: Hydrogel dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Lacrilube ointment', 'interventionNames': ['Other: Lacrilube ointment']}], 'interventions': [{'name': 'Hydrogel dressing', 'type': 'OTHER', 'description': '3x3cm hydrogel dressing over closed eye', 'armGroupLabels': ['1']}, {'name': 'Lacrilube ointment', 'type': 'OTHER', 'description': 'lubricant put into eye (inferior formix)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marie Healy, FRCA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}}}}