Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT01614158
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2012-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058609', 'term': 'Visual Field Tests'}, {'id': 'D014065', 'term': 'Tonometry, Ocular'}], 'ancestors': [{'id': 'D014787', 'term': 'Vision Tests'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION)', 'timeFrame': '2 years', 'description': 'This present research project intends to collect five quantitative test series in order to allow the estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['N-AION', 'perimetry', 'visual field loss', 'Mean Defect', 'Total Loss Volume', 'D-BCVA', 'RAPD', 'retinal nerve fibre thickness/volume', 'optic nerve head'], 'conditions': ['Non-arteritic Ischemic Optic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '24477537', 'type': 'RESULT', 'citation': 'Kernstock C, Beisse F, Wiethoff S, Mast A, Krapp E, Grund R, Dietzsch J, Lagreze W, Fischer D, Schiefer U. Assessment of functional and morphometric endpoints in patients with non-arteritic anterior ischemic optic neuropathy (NAION). Graefes Arch Clin Exp Ophthalmol. 2014 Mar;252(3):515-21. doi: 10.1007/s00417-014-2572-z. Epub 2014 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'This present research project intends to collect five quantitative test series:\n\n* perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) \\[Schiefer 2008\\] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time\n* D-BCVA, using FrACT \\[Bach 2007\\] and EDTRS chart \\[Ferris 1982\\]\n* RAPD (using swinging flashlight test).\n* IOP (using applanation tonometer)\n* RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic disk morphology will be documented by fundus photography. This assessment of the above-mentioned data is needed in order to allow for estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute N-AION (less then 7 days); male and female \\> 18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - physical, intellectual and linguistic abilities, in order to understand the test requirements\n\n* willingness to comply with the protocol (4 visits)\n* 41 - 80 years, informed consent\n* acute N-AION (\\< 7 d)\n* D-BCVA \\> 0.1 (2/20)\n* RAPD ≥ 0.3 logE steps (neutral density filters) and:\n* spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt\n* isocoria, pupil diameter \\> 3 mm\n\nExclusion Criteria:\n\n* diabetic retinopathy and any other orbital, intracranial or optic nerve disease\n* history of epilepsy or significant psychiatric disease\n* medications known to affect visual field sensitivity\n* infections (e.g. keratitis, conjunctivitis, uveitis)\n* severe dry eyes\n* miotic drug\n* amblyopia\n* strabismus\n* any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields, disc imaging or accurate IOP readings\n* cataract with relevant impairment of vision\n* keratoconus\n* intraocular surgery (except for uncomplicated cataract surgery) performed \\< 3 month prior to screening\n* history or signs of any visual pathway affection other than N-AION\n* history or presence of macular disease and / or macular edema\n* ocular trauma'}, 'identificationModule': {'nctId': 'NCT01614158', 'acronym': 'Pilot-SINN', 'briefTitle': 'Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Pilot SINN; Assessment of Visual Field (vf)-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (N-AION)', 'orgStudyIdInfo': {'id': '73/2009B02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute N-AION (< 7 d)', 'description': 'physical, intellectual and linguistic abilities, in order to understand the test requirements\n\n* willingness to comply with the protocol (4 visits)\n* 45 - 80 years, informed consent\n* acute N-AION (\\< 7 d)\n* D-BCVA \\> 0.1 (2/20)\n* RAPD ≥ 0.3 logE steps (neutral density filters)', 'interventionNames': ['Device: perimetry', 'Other: D-BCVA', 'Other: RAPD', 'Device: IOP', 'Device: Spectralis OCT', 'Other: Fundus photography']}], 'interventions': [{'name': 'perimetry', 'type': 'DEVICE', 'otherNames': ['Static Perimetry, Octopus 101, thresholding algorithm'], 'description': 'perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) \\[Schiefer 2008\\] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time', 'armGroupLabels': ['acute N-AION (< 7 d)']}, {'name': 'D-BCVA', 'type': 'OTHER', 'otherNames': ['Best Corrected Visual Acuity, EDTRS Chart'], 'description': 'D-BCVA using EDTRS chart', 'armGroupLabels': ['acute N-AION (< 7 d)']}, {'name': 'RAPD', 'type': 'OTHER', 'otherNames': ['SWIFT-Test'], 'description': 'RAPD using swinging flashlight test', 'armGroupLabels': ['acute N-AION (< 7 d)']}, {'name': 'IOP', 'type': 'DEVICE', 'otherNames': ['intraocular pressure'], 'description': 'IOP using applanation tonometer', 'armGroupLabels': ['acute N-AION (< 7 d)']}, {'name': 'Spectralis OCT', 'type': 'DEVICE', 'otherNames': ['RNFT, RNFV, volume scan, star scan, Spectralis OCT'], 'description': 'RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)', 'armGroupLabels': ['acute N-AION (< 7 d)']}, {'name': 'Fundus photography', 'type': 'OTHER', 'description': 'Optic disk morphology will be documented by fundus photography', 'armGroupLabels': ['acute N-AION (< 7 d)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Ulrich Schiefer, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Freiburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med. Ulrich Schiefer', 'investigatorFullName': 'Ulrich Schiefer', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}