Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:41 PM
Study NCT ID:
NCT01249235
Status:
UNKNOWN
Last Update Posted:
2010-11-29
First Post:
2010-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057968', 'term': 'Transdermal Patch'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-24', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2010-11-24', 'lastUpdatePostDateStruct': {'date': '2010-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Pain Score', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'Sensitivity to light, tearing, foreign body sensation', 'timeFrame': '1 week'}, {'measure': 'Postoperative Complications', 'timeFrame': '1 week', 'description': 'Difficulty removing the bandage lens, the bandage lens has fallen out, graft dislocation'}, {'measure': 'Number of Tylenol #3 tablets required', 'timeFrame': '1 week'}]}, 'conditionsModule': {'conditions': ['Pterygium']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision\n* Size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain)\n* Ability to understand the nature of the procedure and to complete all measurement requirements\n* Adults (age greater than 18)\n\nExclusion Criteria:\n\n* Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)\n* Patients who have had previous ocular surface surgery\n* Contraindications to local anesthetics (such as known allergy)\n* Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)\n* Patients already on systemic analgesics for any other reason (such as rheumatoid arthritis)\n* Allergy to codeine (in order to standardize the systemic analgesic used so that we can compare the effect of bandage contact lens versus 24 hour patching)'}, 'identificationModule': {'nctId': 'NCT01249235', 'briefTitle': 'Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Prospective Randomized Controlled Trial Comparing Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery', 'orgStudyIdInfo': {'id': 'REB-10-0538'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patch', 'description': 'The operative eye will be patched.', 'interventionNames': ['Procedure: Patch or bandage contact lens']}, {'type': 'EXPERIMENTAL', 'label': 'Bandage Contact Lens', 'description': 'The operative eye will have a bandage contact lens', 'interventionNames': ['Procedure: Patch or bandage contact lens']}], 'interventions': [{'name': 'Patch or bandage contact lens', 'type': 'PROCEDURE', 'description': 'Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.', 'armGroupLabels': ['Bandage Contact Lens', 'Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sonia Yeung, MD', 'role': 'CONTACT', 'email': 'sonia.yeung@utoronto.ca'}], 'facility': 'Toronto Western Hospital, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Allan Slomovic, MD', 'role': 'CONTACT', 'email': 'allan.slomovic@utoronto.ca'}], 'overallOfficials': [{'name': 'Allan Slomovic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Western Hospital, University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Allan Slomovic', 'oldOrganization': 'Toronto Western Hospital, University of Toronto'}}}}