Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-29 @ 12:29 AM
Study NCT ID:
NCT02321150
Status:
UNKNOWN
Last Update Posted:
2014-12-30
First Post:
2014-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Technique for the Removal of Pterygiums
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-08-09', 'releaseDate': '2017-10-29'}], 'estimatedResultsFirstSubmitDate': '2017-10-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013537', 'term': 'Sutures'}, {'id': 'D011098', 'term': 'Polyglactin 910'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011091', 'term': 'Polyesters'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-26', 'studyFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Operating Cost', 'timeFrame': 'day 1', 'description': 'Cost Benefit Analysis. Total cost of pterygium surgery using sutures for graft attachment versus cost using cautery for graft attachment will be calculated and compared.'}, {'measure': 'Recurrence', 'timeFrame': '1 year', 'description': 'Any regrowth of the pterygium onto the cornea will be considered a recurrence'}], 'primaryOutcomes': [{'measure': 'Patient Discomfort', 'timeFrame': 'Day 1', 'description': "Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:\n\n0 = no symptom at all;\n\n1. = presence of the symptom but easily tolerated;\n2. = presence of the symptom causing some discomfort;\n3. = presence of the symptom causing discomfort that interferes with usual activity or sleep;\n4. = presence of the symptom that completely interferes with usual activity or sleep."}, {'measure': 'Patient Discomfort', 'timeFrame': 'Week 1', 'description': "Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:\n\n0 = no symptom at all;\n\n1. = presence of the symptom but easily tolerated;\n2. = presence of the symptom causing some discomfort;\n3. = presence of the symptom causing discomfort that interferes with usual activity or sleep;\n4. = presence of the symptom that completely interferes with usual activity or sleep."}, {'measure': 'Patient Discomfort', 'timeFrame': 'Week 2', 'description': "Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:\n\n0 = no symptom at all;\n\n1. = presence of the symptom but easily tolerated;\n2. = presence of the symptom causing some discomfort;\n3. = presence of the symptom causing discomfort that interferes with usual activity or sleep;\n4. = presence of the symptom that completely interferes with usual activity or sleep."}, {'measure': 'Patient Discomfort', 'timeFrame': 'Week 3', 'description': "Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:\n\n0 = no symptom at all;\n\n1. = presence of the symptom but easily tolerated;\n2. = presence of the symptom causing some discomfort;\n3. = presence of the symptom causing discomfort that interferes with usual activity or sleep;\n4. = presence of the symptom that completely interferes with usual activity or sleep."}, {'measure': 'Patient Discomfort', 'timeFrame': 'Week 7', 'description': "Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:\n\n0 = no symptom at all;\n\n1. = presence of the symptom but easily tolerated;\n2. = presence of the symptom causing some discomfort;\n3. = presence of the symptom causing discomfort that interferes with usual activity or sleep;\n4. = presence of the symptom that completely interferes with usual activity or sleep."}, {'measure': 'Patient Discomfort', 'timeFrame': '3 months', 'description': "Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:\n\n0 = no symptom at all;\n\n1. = presence of the symptom but easily tolerated;\n2. = presence of the symptom causing some discomfort;\n3. = presence of the symptom causing discomfort that interferes with usual activity or sleep;\n4. = presence of the symptom that completely interferes with usual activity or sleep."}], 'secondaryOutcomes': [{'measure': 'Operating time', 'timeFrame': 'day 1', 'description': 'Analysis. start time of operation, start time of conjunctival graft attachment and end time of operation will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pterygium', 'Pterygiums', 'Pterygia', 'Graft', 'Autograft', 'Excision', 'Surgery', 'Eye', 'electrocautery', 'polyglactin'], 'conditions': ['Pterygium']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to introduce a new surgical technique for the removal of pterygiums that entails the use of bipolar electrocautery to secure the graft, rather than sutures.\n\nWith this, the objective is to evaluate the benefits of a new technique for pterygium surgery with respect to postoperative patient comfort, surgery time, cost and recurrence rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with one or more pterygiums over age 18\n\nExclusion Criteria:\n\n* Patients with glaucoma'}, 'identificationModule': {'nctId': 'NCT02321150', 'briefTitle': 'A Novel Technique for the Removal of Pterygiums', 'organization': {'class': 'OTHER', 'fullName': 'The University of The West Indies'}, 'officialTitle': 'A Novel Technique for the Removal of Pterygiums', 'orgStudyIdInfo': {'id': 'KJebodhsingh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sutures', 'description': 'After pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures.', 'interventionNames': ['Procedure: Sutures']}, {'type': 'EXPERIMENTAL', 'label': 'Cautery', 'description': 'After pterygium removal the conjunctival graft to cover bare sclera will be secured with bipolar electrocautery, power set at 25 until whitening of tissue observed.', 'interventionNames': ['Procedure: Cautery']}], 'interventions': [{'name': 'Cautery', 'type': 'PROCEDURE', 'otherNames': ['Mentor O&O Wetfield Coagulator'], 'description': '* Pterygium dissected off, corneal bed burred smooth and autograft harvested as per usual technique.\n* Conjunctiva undermined at the recipient site.\n* Relaxing incisions placed at the corners of the recipient site.\n* Graft is slid into place\n* Graft / host interface is gently dried with a Qtip\n* Bipolar cautery is applied after grasping the graft and host conjunctiva gently between cautery forceps.\n\n * Power setting: 25.\n * Duration of cautery: 4 -5 seconds; the tissue should whiten and contract as desiccation and coagulation take place. Some charring may occur.\n* Counter traction is applied to the conjunctiva as the cautery forceps are gently teased off\n* Cautery is applied at the 4 apices of the graft then in between these points.', 'armGroupLabels': ['Cautery']}, {'name': 'Sutures', 'type': 'PROCEDURE', 'otherNames': ['Polyglactin, Vicryl'], 'description': '* Pterygium dissected off, corneal bed burred smooth and autograft harvested as per usual technique.\n* Conjunctiva undermined at the recipient site.\n* Graft is slid into place The graft is secured to host conjunctiva using 7 interrupted sutures', 'armGroupLabels': ['Sutures']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bridgetown', 'country': 'Barbados', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 13.10732, 'lon': -59.62021}}], 'overallOfficials': [{'name': 'Kim N Jebodhsingh, MBBS, DABO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Queen Elizabeth Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of The West Indies', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Ophthalmologist', 'investigatorFullName': 'Dr. Kim Jebodhsingh', 'investigatorAffiliation': 'The University of The West Indies'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-10-29', 'type': 'RELEASE'}, {'date': '2018-08-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. Kim Jebodhsingh, Consultant Ophthalmologist, The University of The West Indies'}}}}