Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT06674369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-05
First Post:
2024-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ongoing Effect of Expansion Prisms Following the Discontinuation of Use on Visual Field Enlargement and Retrograde Ganglion Cell Degeneration in Homonymous Hemianopia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006423', 'term': 'Hemianopsia'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001766', 'term': 'Blindness'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-03', 'studyFirstSubmitDate': '2024-11-03', 'studyFirstSubmitQcDate': '2024-11-03', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Computerised visual field changes', 'timeFrame': 'From enrollment to the end of prism use at 6 months', 'description': 'Changes in Visual field index(VFİ) and mean devation(MD) in dB. Higher values in VFI and MD mean an improvement in visual field'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Homonium hemianopsia', 'Retrograde ganglion cell degeneration', 'Neuroplastisity,', 'Vision therapy,', 'Peli Prism'], 'conditions': ['Homonymous Hemianopsia']}, 'referencesModule': {'references': [{'pmid': '31181393', 'type': 'BACKGROUND', 'citation': 'Garric C, Sebaa A, Caetta F, Perez C, Savatovsky J, Sergent C, Chokron S. Dissociation between objective and subjective perceptual experiences in a population of hemianopic patients: A new form of blindsight? Cortex. 2019 Aug;117:299-310. doi: 10.1016/j.cortex.2019.05.006. Epub 2019 May 18.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1167/16.15.5', 'label': 'The risk of pedestrian collisions with peripheral visual field loss. Journal of vision, 16(15), 5-5'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the long-term effects of Pelli prism in Hemianopia patients who take Prisms for awareness of the area they cannot see.\n\nThe main question it aims to answer is:\n\nDoes the field enlargement observed with the prism continues after the prism is removed? Participants already using Peli prisms as part of their regular medical care for Hemianopia, in the upcoming routine controls their field of vision enlargements will be examined.', 'detailedDescription': 'Hemianopia is a disability-causing condition that usually affects young to middle-aged people and reduces quality of life.Prism applications are one of the rehabilitation methods used to improve the quality of life of these people and ensure their participation in daily life. The Peli prism is the most commonly used prism type. The effect of prism applications is thought to be temporary.The main idea of our study is that Prisms can create longlasting effects by affecting neuroplasticity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '55 Months', 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemianopia patients admitted to the ophthalmology clinic of Okan University Hospital and the ophthalmology clinic of Ankara University Faculty of Medicine were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHomonim Hemianopsia patient age between 18-55 years H.Hemianopia, diagnosed at least six months before the initial examination Neurological condition is suitable for daily activities\n\nExclusion Criteria:\n\n\\- Failure to meet age criteria Hemianopia developed more recently than 6 months ago Having to use medications that affect his/her balance and daily activity'}, 'identificationModule': {'nctId': 'NCT06674369', 'briefTitle': 'Ongoing Effect of Expansion Prisms Following the Discontinuation of Use on Visual Field Enlargement and Retrograde Ganglion Cell Degeneration in Homonymous Hemianopia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Okan University'}, 'officialTitle': 'Timlioğlu İper H.S1, Sahli.E2, İdil Ş.A3,Önal.R.E4 1 PhD.MD Opht.İstanbul Okan University ,ophthalmology and Opticianry ,ORCİD:0000-0003-2112-0602 2 PhD.MD Opht. Ankara University Faculty of Medicine, Low Vision Rehabilitation and Research Center, Department of Ophthalmology, Ankara, Turkey ORCİD:0000-0002-1355-7284 3 MD Opht. Professor. Ankara University Faculty of Medicine, Low Vision Rehabilitation and Research Center, Department of Ophtha', 'orgStudyIdInfo': {'id': '24.08.2022/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': '15 patients between the ages of 22-70 (m=52.0 year) with homonymous hemianopsia', 'description': 'Homonymous hemianopia (HH) patients due to long-standing post-chiasmatic lesions between 2017 and 2020 were included in the study . To eliminate spontaneous neuronal recovery only the patients with hemianopia, diagnosed at least six months before the initial examination and who had undergone full clinical MRI evaluation were included. Initially all patients were applied peripheral field expander 40 D horizontal Peli prisms. In the initial and follow-up examinations, in addition to neurological history, a complete ophthalmologic examination was performed, followed by computerized visual field examination using Estermann binocular field program and Swedish Interactive treshold algorithm program (SITA 30-2) (Zeiss Humphrey3-850). Ganglion cell layer thickness was measured by OCT (Zeiss Cirrus HD Oct) and compared with the normal retinal image.', 'interventionNames': ['Device: Peli prism for hemianopia']}], 'interventions': [{'name': 'Peli prism for hemianopia', 'type': 'DEVICE', 'otherNames': ['Computerised visual filed examination', 'Optic coherence tomography'], 'description': "Peli prism uses high-powered prisms (40 Dioptre) that expand a hemianopic patient's awareness of their blind side. This awareness enables patients to better detect obstacles and navigate around them. Effect of the prism considered as temporary We investigated whether the effect persists after the prism is removed.To understand the persistence of the effect, we examined the changes in the visual field with CVF (Computerized visual field examination)before the prism was applied, with the prism and 1 week after the prism was removed.", 'armGroupLabels': ['15 patients between the ages of 22-70 (m=52.0 year) with homonymous hemianopsia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34939', 'city': 'Istanbul', 'state': 'Tuzla', 'country': 'Turkey (Türkiye)', 'facility': 'Okan University Hospital Ophthalmology clinic', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Aysun Sefay İdil, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Üniversity'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '2.12.2024', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'Open access for academics'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hatice Semrin Timlioglu İper', 'investigatorAffiliation': 'Okan University'}}}}