Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT00326560
Status:
UNKNOWN
Last Update Posted:
2006-06-16
First Post:
2006-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Glue With Sutures for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2007-09'}, 'lastUpdateSubmitDate': '2006-06-15', 'studyFirstSubmitDate': '2006-05-15', 'studyFirstSubmitQcDate': '2006-05-15', 'lastUpdatePostDateStruct': {'date': '2006-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgery time'}, {'measure': 'Patient discomfort at day one, week one, two, four'}, {'measure': 'Recurrence rate at months three, six, twelve'}]}, 'conditionsModule': {'keywords': ['Pterygium excision', 'Cut and paste', 'Tisseel fibrin glue', 'Conjunctival autograft'], 'conditions': ['Pterygium']}, 'referencesModule': {'references': [{'pmid': '15948780', 'type': 'BACKGROUND', 'citation': 'Koranyi G, Seregard S, Kopp ED. The cut-and-paste method for primary pterygium surgery: long-term follow-up. Acta Ophthalmol Scand. 2005 Jun;83(3):298-301. doi: 10.1111/j.1600-0420.2005.00465.x.'}, {'pmid': '15808260', 'type': 'BACKGROUND', 'citation': 'Uy HS, Reyes JM, Flores JD, Lim-Bon-Siong R. Comparison of fibrin glue and sutures for attaching conjunctival autografts after pterygium excision. Ophthalmology. 2005 Apr;112(4):667-71. doi: 10.1016/j.ophtha.2004.08.028.'}, {'pmid': '15205236', 'type': 'BACKGROUND', 'citation': 'Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. doi: 10.1136/bjo.2003.032854.'}, {'pmid': '19702708', 'type': 'DERIVED', 'citation': 'Hall RC, Logan AJ, Wells AP. Comparison of fibrin glue with sutures for pterygium excision surgery with conjunctival autografts. Clin Exp Ophthalmol. 2009 Aug;37(6):584-9. doi: 10.1111/j.1442-9071.2009.02105.x.'}]}, 'descriptionModule': {'briefSummary': 'Pterygium excision surgery involves excising the abnormal growth from the cornea and filling the defect with a conjunctival (white of the eye) graft from the superior part of the eye. This is the best method of pterygium excision but it is recognised that in 10-15% of cases it will grow back (recurrence). Currently the investigators use small sutures to sew the graft in place. Recently it has been described that glue can be used instead of the sutures. It has been shown in one study that the patient discomfort is less and so is the surgical time. The investigators want to confirm these findings and also compare the recurrence rate between the two types of surgery. They plan to complete a prospective, randomised, control trial of 40 participants. Twenty will have traditional pterygium surgery with the conjunctival autograft sutured. Twenty will have cut and paste surgery with Tisseel glue. The two groups of participants will be compared for pain and discomfort, surgery time, and recurrence rate of the pterygia.', 'detailedDescription': 'This is a prospective, randomised, control trial of 40 participants. Twenty patients in each arm. Twenty patients undergo standard pterygium excision with the conjunctival autograft sutured. Twenty patients undergo pterygium surgery with Tisseel glue replacing sutures as a method of attaching the conjunctival autograft. Participants will be reviewed, selected, and consented on a pre-assessment day. Surgery will be performed 10 at a time on an all day surgery operating list. Randomisation of the surgery type will be done at the time of surgery after the pterygium has been excised and the autograft taken. One surgeon (R. Hall) will perform all of the procedures. Follow-up will occur at week 1, 2, 4, 26, 52. A questionnaire answered by participants will indicate their pain, foreign body sensation, tearing, and discomfort. There will be observation of any complications such as graft failure and recurrence rate. Photographs will be taken pre-op and post-op.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary pterygium\n\nExclusion Criteria:\n\n* Ocular surface disease\n* Previous pterygium surgery'}, 'identificationModule': {'nctId': 'NCT00326560', 'briefTitle': 'Comparison of Glue With Sutures for Pterygium Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wellington Hospital'}, 'officialTitle': 'Comparison of Cut and Paste With Sutured Autograft Pterygium Excision', 'orgStudyIdInfo': {'id': 'CEN/06/03/021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pterygium excision and conjunctival autograft', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6001', 'city': 'Wellington', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Reece C Hall, MBChB', 'role': 'CONTACT', 'email': 'reece.hall@ccdhb.org.nz', 'phone': '0064 4 3855999', 'phoneExt': 'page2566'}, {'name': 'Reece C Hall, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wellington Ophthalmology Department, Capital Coast District Health Board', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'centralContacts': [{'name': 'Reece C Hall, MBChB', 'role': 'CONTACT', 'email': 'reece.hall@ccdhb.org.nz', 'phone': '0064 4 3855999', 'phoneExt': 'pager2566'}], 'overallOfficials': [{'name': 'Reece C Hall, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Coast District Health Board'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wellington Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}]}}}