Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05955118
Status:
UNKNOWN
Last Update Posted:
2023-07-21
First Post:
2023-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydrus Microstent as a Quality of Life Consideration
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-09', 'size': 488800, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-25T16:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glaucoma Symptom Score (GSS) Score', 'timeFrame': '3 months', 'description': 'GSS is a cross-sectional study of symptoms, functional impairment, and vision-targeted health-related quality of life among persons with glaucoma, scored 0-100, with a higher score being more favorable (ie fewer adverse symptoms).'}], 'secondaryOutcomes': [{'measure': 'Number of Medication Reduction for Glaucoma', 'timeFrame': '3 months', 'description': 'The number of glaucoma medications used before the intervention are compared to the number used after.'}, {'measure': 'Ocular surface disease (OSD) assessment', 'timeFrame': '3 months', 'description': 'The Oxford Grading System is used to grade the amount of corneal and conjunctival fluorescein staining, scored 0 (none) to V.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The study aims to identify if Hydrus microstent implantation in patients with open angle glaucoma (OAG) at the time of cataract surgery improves quality of life for patients and explore what quality of life factors motivate patients.', 'detailedDescription': 'Prospective, interventional single arm study of patient-reported outcomes (PRO) via GSS with pre and post ocular surface disease assessment in subjects undergoing bilateral phaco and Hydrus implantation; Study will also explore other QOL factors that may motivate patients to accept Hydrus via Glauc-QOL36 and customized questions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with mild to moderate OAG undergoing bilateral combined cataract surgery \\& Hydrus Microstent implantation', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of mild to moderate open angle glaucoma as defined by with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus Microstent\n* Current treatment with one or more ocular hypotensive medication\n* Corneal thickness between 470 to 610µm\n* Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively\n\nExclusion Criteria:\n\n* Clinical diagnosis of secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma)\n* corneal opacity or angle abnormalities that make visualizing the angle difficult\n* Past ocular surgery\n* History of ocular, systemic medications, or systemic diseases/co-morbidities that significantly impact on quality of life or vision (e.g. advanced macular degeneration, autoimmune diseases, mental illness/depression, uncontrolled systemic disease on polypharmacy)\n* Severe dry eye requiring secretagogues, serum eyedrops, topical corticosteroids, amniotic membrane grafts"}, 'identificationModule': {'nctId': 'NCT05955118', 'briefTitle': 'Hydrus Microstent as a Quality of Life Consideration', 'organization': {'class': 'OTHER', 'fullName': 'InSight Vision Center Medical Group, Inc'}, 'officialTitle': 'Hydrus Microstent as a Quality of Life Consideration', 'orgStudyIdInfo': {'id': 'HQoL-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Open Angle Glaucoma', 'description': 'Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery \\& Hydrus Microstent implantation.', 'interventionNames': ['Device: Hydrus Microstent']}], 'interventions': [{'name': 'Hydrus Microstent', 'type': 'DEVICE', 'description': 'Hydrus Microstent placed at the time of cataract surgery', 'armGroupLabels': ['Open Angle Glaucoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93720', 'city': 'Fresno', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Terri Smith', 'role': 'CONTACT', 'phone': '559-449-5050'}, {'name': 'Eric Poulsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Terri Smith', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}], 'centralContacts': [{'name': 'Terri Smith', 'role': 'CONTACT', 'email': 'tsmith@insightvisioncenter.com', 'phone': '5594495050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Journal publication. Congress presentation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InSight Vision Center Medical Group, Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist', 'investigatorFullName': 'Eric Poulsen', 'investigatorAffiliation': 'InSight Vision Center Medical Group, Inc'}}}}