Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT02641132
Status:
UNKNOWN
Last Update Posted:
2015-12-29
First Post:
2015-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-23', 'studyFirstSubmitDate': '2015-12-23', 'studyFirstSubmitQcDate': '2015-12-23', 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial cell count', 'timeFrame': '3 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pterygium']}, 'referencesModule': {'references': [{'pmid': '18520505', 'type': 'BACKGROUND', 'citation': 'Avisar R, Avisar I, Bahar I, Weinberger D. Effect of mitomycin C in pterygium surgery on corneal endothelium. Cornea. 2008 Jun;27(5):559-61. doi: 10.1097/ICO.0b013e318165b158.'}, {'pmid': '18992871', 'type': 'BACKGROUND', 'citation': 'Bahar I, Kaiserman I, Lange AP, Slomovic A, Levinger E, Sansanayudh W, Slomovic AR. The effect of mitomycin C on corneal endothelium in pterygium surgery. Am J Ophthalmol. 2009 Mar;147(3):447-452.e1. doi: 10.1016/j.ajo.2008.08.035. Epub 2008 Nov 7.'}, {'pmid': '19654528', 'type': 'BACKGROUND', 'citation': 'Avisar R, Apel I, Avisar I, Weinberger D. Endothelial cell loss during pterygium surgery: importance of timing of mitomycin C application. Cornea. 2009 Sep;28(8):879-81. doi: 10.1097/ICO.0b013e3181a3900c.'}, {'pmid': '21236405', 'type': 'BACKGROUND', 'citation': 'Kheirkhah A, Izadi A, Kiarudi MY, Nazari R, Hashemian H, Behrouz MJ. Effects of mitomycin C on corneal endothelial cell counts in pterygium surgery: role of application location. Am J Ophthalmol. 2011 Mar;151(3):488-93. doi: 10.1016/j.ajo.2010.09.014. Epub 2011 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%', 'detailedDescription': 'To evaluate the change in endothelial cell count in patients after pterygium surgery with mitomycin C (MMC) 0.02% for 2 minutes in 2 groups.\n\n* The control group: application of MMC after excision of the body of the pterygium without the head\n* The study group: application of MMC after excision of the body and the head of the pterygium'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males/females \\>18 Years old\n* Pterygium with indication to operate\n* Subjects that are able to sign an informed consent\n\nExclusion Criteria:\n\n* Recurrent Pterygium/suspected tumor lesion\n* Patients with endothelial cell diseases\n* Patients after anterior segment surgery\n* Patients with low compliance\n* Patients without judgment ability\n* Pregnancy\n* Patients participated in another survey'}, 'identificationModule': {'nctId': 'NCT02641132', 'acronym': 'PHB-MMC1', 'briefTitle': 'Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.', 'orgStudyIdInfo': {'id': '0091-13-MMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pterygium surgery: Head and body.', 'description': 'Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.', 'interventionNames': ['Drug: Mitomycin C 0.02%', 'Procedure: Pterygium surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pterygium surgery: Body.', 'description': 'Application of Mitomycin C 0.02% after excision of the body only of the pterygium.', 'interventionNames': ['Drug: Mitomycin C 0.02%', 'Procedure: Pterygium surgery']}], 'interventions': [{'name': 'Mitomycin C 0.02%', 'type': 'DRUG', 'description': 'Pterygium excision with application of mitomycin C', 'armGroupLabels': ['Pterygium surgery: Body.', 'Pterygium surgery: Head and body.']}, {'name': 'Pterygium surgery', 'type': 'PROCEDURE', 'description': 'Two different procedures- excision of the head and the body and excision of the head only', 'armGroupLabels': ['Pterygium surgery: Body.', 'Pterygium surgery: Head and body.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'state': 'Israel', 'country': 'Israel', 'facility': 'Sackler school of medicine', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir medical centre', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Fani Segev, MD', 'role': 'CONTACT', 'email': 'fsegev@netvision.net.il', 'phone': '+792526995044'}, {'name': 'Leena Asalee, MD', 'role': 'CONTACT', 'email': 'leenaasalee@yahoo.com', 'phone': '+972543031396'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Ophthalmology, Meir medical centre, Kfar saba, Isreal', 'investigatorFullName': 'segev fani', 'investigatorAffiliation': 'Meir Medical Center'}}}}