Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-22 @ 6:48 AM
Study NCT ID:
NCT06523751
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D017889', 'term': 'Exfoliation Syndrome'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-04', 'size': 843244, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-16T12:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP', 'timeFrame': 'before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively', 'description': 'Intraocular pressure measured by Goldmann applanation tonometry'}, {'measure': 'Outflow facility', 'timeFrame': 'before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively', 'description': 'Outflow facility is measured by the use of a pneumatonometer'}, {'measure': 'Surgical success', 'timeFrame': 'at month three', 'description': 'surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ab Interno Trabeculectomy', 'Trabeculopuncture', 'Open Angle Glaucoma'], 'conditions': ['Open Angle Glaucoma', 'Pseudoexfoliation Glaucoma']}, 'referencesModule': {'references': [{'pmid': '35732782', 'type': 'BACKGROUND', 'citation': 'Verma-Fuehring R, Dakroub M, Han H, Hillenkamp J, Loewen NA. Trabeculopuncture as a predictive test of distal outflow resistance in canal-based surgery. Sci Rep. 2022 Jun 22;12(1):10584. doi: 10.1038/s41598-022-13990-9.'}, {'pmid': '4022580', 'type': 'BACKGROUND', 'citation': 'Epstein DL, Melamed S, Puliafto CA, Steinert RF. Neodymium: YAG laser trabeculopuncture in open-angle glaucoma. Ophthalmology. 1985 Jul;92(7):931-7. doi: 10.1016/s0161-6420(85)33932-5.'}, {'pmid': '3977666', 'type': 'BACKGROUND', 'citation': 'Melamed S, Pei J, Puliafito CA, Epstein DL. Q-switched neodymium-YAG laser trabeculopuncture in monkeys. Arch Ophthalmol. 1985 Jan;103(1):129-33. doi: 10.1001/archopht.1985.01050010135037.'}, {'pmid': '3173993', 'type': 'BACKGROUND', 'citation': 'Del Priore LV, Robin AL, Pollack IP. Long-term follow-up of neodymium: YAG laser angle surgery for open-angle glaucoma. Ophthalmology. 1988 Feb;95(2):277-81. doi: 10.1016/s0161-6420(88)33195-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.', 'detailedDescription': 'The aim of this study is to develop a non-invasive predictive test for the function of the distal outflow tract after ab interno trabeculectomy for open angle glaucoma. We hypothesize that the ocular pressure drop and outflow change after preoperative trabeculectomy may predict the success of ab interno trabeculectomy. The results of this study should allow trabeculopuncture to be used to select the most appropriate procedure for the individual patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* individuals ≥ 18 years of age\n* clinical diagnosis of: primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma\n* uncontrolled intraocular pressure (IOP) with maximally tolerated medical therapy\n* progressive thinning of retinal nerve fiber layer assessed by Spectral domain optical coherence tomography (p \\< 0.05)\n* progression of visual field defects\n* visually significant cataract and indication to reduce IOP or glaucoma medication burden\n\nExclusion Criteria:\n\n* clinical diagnosis of neovascular glaucoma, angle-closure glaucoma, uveitic glaucoma, neovascular glaucoma\n* prior glaucoma surgery\n* preexisting conditions affecting the episcleral venous pressure including Grave's ophthalmopathy, Sturge-Weber syndrome, Arteriovenous fistulas (carotid-cavernous fistula)"}, 'identificationModule': {'nctId': 'NCT06523751', 'briefTitle': 'Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy', 'orgStudyIdInfo': {'id': 'IRB 113-21-me'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trabeculopuncture', 'description': 'Individuals undergo neodymium-doped yttrium aluminum garnet (Nd:YAG) trabeculopuncture prior to ab interno trabeculectomy.', 'interventionNames': ['Diagnostic Test: Trabeculopuncture']}], 'interventions': [{'name': 'Trabeculopuncture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Trabeculopuncture is performed with a Nd:YAG laser on the trabecular meshwork. Four punctures are created along the 180° nasal trabecular meshwork.', 'armGroupLabels': ['Trabeculopuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Raoul Verma-Führing, MD', 'role': 'CONTACT', 'email': 'vermafuehr_R@ukw.de', 'phone': '0049 93120120662'}], 'facility': 'Uniklinikum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'centralContacts': [{'name': 'Raoul Verma-Fuehring, MD', 'role': 'CONTACT', 'email': 'vermafuehr_R@ukw.de', 'phone': '+49 93120120662'}], 'overallOfficials': [{'name': 'Daniel Kampik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology University Hospital Würzburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}