Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-02 @ 9:04 AM
Study NCT ID:
NCT04406467
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2020-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2020-05-24', 'studyFirstSubmitQcDate': '2020-05-24', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 're-intervention rate', 'timeFrame': '3 months', 'description': 'This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation'}], 'secondaryOutcomes': [{'measure': 'Change in intraocular pressure', 'timeFrame': '1 day, 1 week, 1 month and 3 months', 'description': 'will be assessed as a % change in intraocular pressure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Glaucoma surgery', 'Xen Gel Stent'], 'conditions': ['Glaucoma, Open-Angle']}, 'referencesModule': {'references': [{'pmid': '32200534', 'type': 'BACKGROUND', 'citation': 'Panarelli JF, Yan DB, Francis B, Craven ER. XEN Gel Stent Open Conjunctiva Technique: A Practical Approach Paper. Adv Ther. 2020 May;37(5):2538-2549. doi: 10.1007/s12325-020-01278-1. Epub 2020 Mar 21.'}, {'pmid': '33321200', 'type': 'DERIVED', 'citation': 'Do A, McGlumphy E, Shukla A, Dangda S, Schuman JS, Boland MV, Yohannan J, Panarelli JF, Craven ER. Comparison of Clinical Outcomes with Open Versus Closed Conjunctiva Implantation of the XEN45 Gel Stent. Ophthalmol Glaucoma. 2021 Jul-Aug;4(4):343-349. doi: 10.1016/j.ogla.2020.12.003. Epub 2020 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'To measure surgical success of open vs closed conjunctiva with Xen implantation.', 'detailedDescription': 'This retrospective, single-arm multicenter study included \\>100 eyes (\\>100 patients) with glaucoma refractory to medical therapy. All surgeries were performed by two groups of surgeons at Johns Hopkins University and the sub-investigator group at New York University. Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or application of mitomycin-C.\n\nSuccess rates will be determined based on need for re-intervention and intraocular pressure control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the two institutions with elevated IOP and required surgery to lower IOP.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Require surgery for uncontrolled glaucoma\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04406467', 'briefTitle': 'Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach', 'orgStudyIdInfo': {'id': 'IRB00201210'}, 'secondaryIdInfos': [{'id': '133133', 'type': 'OTHER_GRANT', 'domain': 'Allergan Inc.'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Xen Gel Stent', 'type': 'DEVICE', 'description': 'Ab-interno or Ab-Externa Xen with closed or open conjunctiva.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Univeristy', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified internal use data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}