Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-01-22 @ 1:07 AM
Study NCT ID:
NCT00863018
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2009-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Endothelium After Glaucoma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D065306', 'term': 'Corneal Injuries'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area', 'timeFrame': '1 and 2 years longitudinal follow up'}], 'secondaryOutcomes': [{'measure': 'Clinical factors associated with the damage of corneal endothelium after glaucoma surgery', 'timeFrame': '1 and 2 years longitudinal follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Corneal endothelial cell', 'Specular microscopy', 'Glaucoma implant surgery', 'Ahmed glaucoma valve', 'Trabeculectomy'], 'conditions': ['Glaucoma', 'Corneal Damage', 'Intraocular Pressure']}, 'referencesModule': {'references': [{'pmid': '19505676', 'type': 'DERIVED', 'citation': 'Lee EK, Yun YJ, Lee JE, Yim JH, Kim CS. Changes in corneal endothelial cells after Ahmed glaucoma valve implantation: 2-year follow-up. Am J Ophthalmol. 2009 Sep;148(3):361-7. doi: 10.1016/j.ajo.2009.04.016. Epub 2009 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area will be analyzed and compared to the baseline and between the types of the surgeries.', 'detailedDescription': 'To study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Specular microscopy using non-contact type specular microscope (Noncon Robo SP-8000, Konan Medical Inc., Tokyo, Japan) was performed by one experienced examiner before surgery and 1, 6, 12, 18, and 24 months after surgery. All examinations were done at the center, superior, superonasal, and superotemporal area of the cornea, while the patient maintain fixation at the target in the equipment. The follow-up was stopped if serious complication requiring surgical treatment was developed or additional intraocular pressure lowering surgery is needed, and the data before the second surgery were collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who need glaucoma surgery for intraocular pressure control\n\nExclusion Criteria:\n\n* congenital glaucoma\n* Pre-existing corneal abnormality\n* lost from follow up without any ocular problem within 6 months from surgery'}, 'identificationModule': {'nctId': 'NCT00863018', 'briefTitle': 'Corneal Endothelium After Glaucoma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chungnam National University'}, 'officialTitle': 'Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery', 'orgStudyIdInfo': {'id': 'CNUMC-09-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Eyes with glaucoma and on anti-glaucoma medication but without glaucoma surgery'}, {'label': 'Implant surgery', 'description': 'Eyes underwent Ahmed glaucoma valve implantation'}, {'label': 'Trabeculectomy', 'description': 'Eyes underwent conventional trabeculectomy with mitomycin-C'}]}, 'contactsLocationsModule': {'locations': [{'zip': '301-721', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'overallOfficials': [{'name': 'Young-ha Lee, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Institute for Medical Science, Chungnam National University'}, {'name': 'Chang-sik Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology, College of Medicine, Chungnam National University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chungnam National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Chang-sik Kim', 'investigatorAffiliation': 'Chungnam National University'}}}}