Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT01511094
Status:
UNKNOWN
Last Update Posted:
2012-01-18
First Post:
2011-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-17', 'studyFirstSubmitDate': '2011-10-14', 'studyFirstSubmitQcDate': '2012-01-17', 'lastUpdatePostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra Ocular Pressure', 'timeFrame': 'Change from Baseline in Intra Ocular Pressure at 20 months', 'description': 'The mean of at least three measures at 8:00 am two weeks before surgery. After intervention, the Intra Ocular Pressure was measured on the day after, one week after, two weeks after and every month at the same time until the end of the study (an expected average of 20 months).'}], 'secondaryOutcomes': [{'measure': 'Central Corneal Thickness', 'timeFrame': 'Two weeks before, six months after and one year after intervention'}, {'measure': 'Central corneal endothelial cell density', 'timeFrame': 'Two weeks before, six months after intervention and one year after intervention'}, {'measure': 'Best correct visual acuity', 'timeFrame': 'Two weeks before, six months after and one year after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ab-interno trabeculectomy,', 'intraocular pressure,', 'open angle glaucoma', 'trabeculectomy', 'Goniocurettage', 'Non-Filtering Surgery'], 'conditions': ['Open-Angle Glaucoma', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '9215060', 'type': 'BACKGROUND', 'citation': 'Jacobi PC, Dietlein TS, Krieglstein GK. Technique of goniocurettage: a potential treatment for advanced chronic open angle glaucoma. Br J Ophthalmol. 1997 Apr;81(4):302-7. doi: 10.1136/bjo.81.4.302.'}, {'pmid': '10334341', 'type': 'BACKGROUND', 'citation': 'Jacobi PC, Dietlein TS, Krieglstein GK. Goniocurettage for removing trabecular meshwork: clinical results of a new surgical technique in advanced chronic open-angle glaucoma. Am J Ophthalmol. 1999 May;127(5):505-10. doi: 10.1016/s0002-9394(98)00448-6.'}, {'pmid': '10080211', 'type': 'BACKGROUND', 'citation': 'Jacobi PC, Dietlein TS, Krieglstein GK. Microendoscopic trabecular surgery in glaucoma management. Ophthalmology. 1999 Mar;106(3):538-44. doi: 10.1016/S0161-6420(99)90113-6.'}, {'pmid': '11219641', 'type': 'BACKGROUND', 'citation': 'Johnson DH, Johnson M. How does nonpenetrating glaucoma surgery work? Aqueous outflow resistance and glaucoma surgery. J Glaucoma. 2001 Feb;10(1):55-67. doi: 10.1097/00061198-200102000-00011.'}, {'pmid': '17471324', 'type': 'BACKGROUND', 'citation': 'Minckler D, Baerveldt G, Ramirez MA, Mosaed S, Wilson R, Shaarawy T, Zack B, Dustin L, Francis B. Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma. Trans Am Ophthalmol Soc. 2006;104:40-50.'}]}, 'descriptionModule': {'briefSummary': 'The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with good vision.', 'detailedDescription': 'A prospective study in 33 eyes (32 patients) with uncontrolled open angle glaucoma under clinical treatment. The trabecular tissue was scraped away from the angle (goniocurettage) in about 100 degrees by means of an instrument similar to a microchalazion curette. The goniocurettage was done under direct visualization of the angle through a gonioscopy lens (Swan-Jacob) and a surgical microscope. Using the 17.0 SPSS software the investigators compared the intraocular pressure, the numbers of antiglaucomatous medications, the best correct visual acuity, the development of cataract, the central corneal thickness,the impact on the visual field, the impact on the optic nerve head and the central corneal endothelial cell density before and after the goniocurettage, and the intra and post operative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Disc and/or visual field findings consistent with Primary Open Angle Glaucoma\n* Uncontrolled intraocular pressure (≥21 mm Hg) or progressive glaucomatous neuropathy despite maximum tolerated medical therapy\n* 40 years old or over\n* Visual acuity higher than 0.2\n* Open angles (greater or equal to Shaffer grade II)\n\nExclusion Criteria:\n\n* Previous ocular surgery\n* History of glaucoma laser treatment\n* History of ocular trauma\n* Cyclodestructive procedures\n* Corneal edema or opacities\n* Endothelial decompensation\n* History of uveitis\n* Secondary glaucoma\n* neovascularization of the iris or angle\n* Congenital anterior segment abnormalities\n* Anatomically confusing angles without clear definition of the scleral spur or meshwork and inability to maintain follow-up'}, 'identificationModule': {'nctId': 'NCT01511094', 'acronym': 'GC', 'briefTitle': 'Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications', 'orgStudyIdInfo': {'id': 'Gonio-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye Surgery', 'description': 'Goniocurettage was used to treat open angle glaucoma patients', 'interventionNames': ['Procedure: Goniocurettage']}], 'interventions': [{'name': 'Goniocurettage', 'type': 'PROCEDURE', 'otherNames': ['Ab interno glaucoma precedure', 'Open angle glacuoma surgery', 'Non filtering glaucoma procedure'], 'description': 'Ab interno surgery consisting on scraped away the trabecular tissue from the angle (goniocurettage) removing segments of pathologically altered trabecular meshwork from the scleral sulcus', 'armGroupLabels': ['Eye Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'overallOfficials': [{'name': 'Tiago T Souza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Minas Gerais'}, {'name': 'Sebastiao Cronemberger, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tiago Tomaz de Souza', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}