Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01961193
Status:
UNKNOWN
Last Update Posted:
2013-10-11
First Post:
2013-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065306', 'term': 'Corneal Injuries'}], 'ancestors': [{'id': 'D005131', 'term': 'Eye Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003261', 'term': 'Contact Lenses'}, {'id': 'D000070635', 'term': 'Punctal Plugs'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-10', 'studyFirstSubmitDate': '2013-10-01', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of corneal damage', 'timeFrame': 'From date of randomization until date of dischrage from ICU or date of death from any cause whichever came first assessed up to 2 months.', 'description': 'To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.'}], 'secondaryOutcomes': [{'measure': 'Presence of infection', 'timeFrame': 'From date of randomization until date of dischrage from ICU or date of death from any cause whichever came first assessed up to 2 months', 'description': 'Results of bacterial cultures'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['critically ill patients', 'punctal plug', 'corneal injuries'], 'conditions': ['Contact Lens and Punctal Plug in Preventing Corneal Injuries']}, 'descriptionModule': {'briefSummary': 'Study Rationale:\n\nThe insertion of a bandage contact lens or punctal plug in a defined group of patients admitted to the ICU may be more effective than standard care in decreasing the incidence of corneal injuries.\n\nStudy Objectives:\n\n1. To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.\n2. To assess the safety of a contact bandage lens and punctal plug in critically ill patients.', 'detailedDescription': 'This is a prospective, randomized study\n\nStudy Population:\n\nConsecutive patients admitted to the General Intensive Care Unit of the Rabin Medical Center and Sharon Hospital Medical Center over a 6-month period who meet criteria for inclusion.\n\nProcedures:\n\nConsecutive patients meeting inclusion criteria will be enrolled in the study. Patients will be randomized to 3 groups: the bandage contact lens group, who will be assigned to insertion of a bandage contact lens; the punctal plug group, who will be assigned to the insertion of punctal plugs; and the control group, who will be assigned to standard eye care as currently practiced in the ICU.\n\nIn addition, patients in the study will be examined every 4 days by a physician from the ophthalmology department and at either discharge from the ICU or at time of death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients must be \\> 18 years of age. Patients who meet the following criteria will be considered eligible for the study: i) require mechanical ventilation; ii) require continuous infusion of sedative medication with or without neuromuscular paralysis; iii) anticipated ICU stay \\> 5 days.\n\nExclusion Criteria:\n\n\\- Patients will be excluded if there is any preexisting corneal disease or an ophthalmic injury related to the present admission (e.g. ophthalmic trauma) to the ICU.'}, 'identificationModule': {'nctId': 'NCT01961193', 'acronym': 'COMLENPLSTAN', 'briefTitle': 'A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries Related to Exposure in Patients Admitted to the General Intensive Care Unit.', 'orgStudyIdInfo': {'id': '7517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bandage contact lens', 'description': 'A bandage contact lens will be inserted by a physician from the ophthalmology department within the first 24 hours of admission of the patient to the ICU. The position of the lens will be confirmed. The lens will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit.', 'interventionNames': ['Device: contact lens']}, {'type': 'EXPERIMENTAL', 'label': 'punctal plug', 'description': 'A punctal plug (Painless Silicon Plugs),will be inserted into each eye. Lubricant drops will be instilled four times daily into each eye. The punctal plug will remain in- situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit at which time it will be removed by a physician from the ophthalmology department.', 'interventionNames': ['Device: punctal plug']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Hydroxyethylcellulose drops will be inserted into each eye four times a day and erythromycin ophthalmic ointment will be applied three times a day as well.'}], 'interventions': [{'name': 'contact lens', 'type': 'DEVICE', 'otherNames': ['contact bandage lens'], 'description': 'A bandage contact lens will be inserted by a physician from the ophthalmology department within the first 24 hours of admission of the patient to the ICU. The position of the lens will be confirmed. The lens will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit.', 'armGroupLabels': ['bandage contact lens']}, {'name': 'punctal plug', 'type': 'DEVICE', 'otherNames': ['Painless Silicon Plugs'], 'description': 'A punctal plug will be inserted into each eye. Lubricant drops ethylcellulose) will be instilled four times daily into each eye. The punctal plug will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit at which time it will be removed by a physician from the ophthalmology department.', 'armGroupLabels': ['punctal plug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'contacts': [{'name': 'Jonathan Cohen, MD Professor', 'role': 'CONTACT', 'email': 'jonatanc@gmail.com', 'phone': '97239376524'}, {'name': 'Milana Grinev, RN Study Coordinator', 'role': 'CONTACT', 'email': 'milang@clalit.org.il', 'phone': '97239376521'}, {'name': 'Pierre Singer, MD, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jonathan Cohen, MD Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shaul Lev, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Milana Grinev, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Inbal Avisar, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rabin MC Beilinson', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Jonathan Cohen, MD Prof', 'role': 'CONTACT', 'email': 'jonatanc@clalit.org.il', 'phone': '9729376524'}, {'name': 'Milana Grinev, Study Coordinator', 'role': 'CONTACT', 'email': 'milang@clalit.org.il', 'phone': '97239376521'}], 'overallOfficials': [{'name': 'Jonathan Cohen, MD Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "ICU dep't , Rabin MC Campus Beilinson"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Jonathan Cohen', 'investigatorFullName': 'jonatan cohen', 'investigatorAffiliation': 'Rabin Medical Center'}}}}