Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT05703867
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2023-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '1999-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-28', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '1999-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean logMAR BCVA', 'timeFrame': 'Week 1', 'description': 'Mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) following the last treatment'}], 'secondaryOutcomes': [{'measure': 'Proportion of improved, stable or worsened BCVA', 'timeFrame': 'Week 1', 'description': 'Proportion of eyes with improved, stable or worsened BCVA, and BCVA with both eyes open'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration', 'Nonexudative Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular degeneration.\n\nParticipants are assessed at baseline for visual acuity and treated for 4 consecutive days for a total of 8 sessions (2 per day) with microcurrent stimulation. A follow-up visit is conducted to evaluate the participant and collect follow-up visual acuity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged at least 50 years with dry AMD in at least one eye\n\nExclusion Criteria:\n\n* Eye diseases other than dry AMD\n* Implanted electrical devices\n* Seizure disorders'}, 'identificationModule': {'nctId': 'NCT05703867', 'briefTitle': 'Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration', 'organization': {'class': 'INDIV', 'fullName': 'Jarding, John, OD'}, 'officialTitle': 'Interventional Study of Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration', 'orgStudyIdInfo': {'id': 'OL101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active microcurrent therapy', 'interventionNames': ['Device: Active microcurrent therapy']}], 'interventions': [{'name': 'Active microcurrent therapy', 'type': 'DEVICE', 'description': 'Non-invasive transpalpebral microcurrent therapy delivery to the upper and lower eyelids', 'armGroupLabels': ['Active microcurrent therapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jarding, John, OD', 'class': 'INDIV'}, 'collaborators': [{'name': "Professor Timothy Jackson, King's College", 'class': 'UNKNOWN'}, {'name': 'i-Lumen Scientific, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}