Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-14 @ 1:13 AM
Study NCT ID:
NCT02941406
Status:
UNKNOWN
Last Update Posted:
2016-10-21
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MP3 (Microperimeter 3) Reproducibility in Healthy Subjects and Macular Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-20', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducibility of retinal sensitivity measurements using microperimetry', 'timeFrame': 'Two measurement within one week', 'description': 'Two study measurements are scheduled within one week. Test-retest reproducibility will be assessed for retinal sensitivity using the coefficient of repeatability and Bland-Altman diagrams.'}], 'secondaryOutcomes': [{'measure': 'Comparison of reproducibility of retinal sensitivity measurements assessed with microperimetry and conventional perimetry', 'timeFrame': 'Two measurement within one week', 'description': 'In addition to microperimetry conventional perimetry will be performed and reproducibility of both devices will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retina', 'Perimetry'], 'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to investigate the reproducibility of the MP3 and to compare the results with conventional perimetry using the Octopus 101 in healthy subjects and patients with macular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '10 healthy subjects 20 macular patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for healthy subjects\n\n* Men and Women aged 18 and older\n* Written informed consent\n* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant\n* Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant\n\nInclusion criteria for macular disease patients\n\n* Men and Women aged 18 and older\n* Written informed consent\n* Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane)\n\nAny of the following will exclude a subject from the study:\n\n* Any opacities (corneal scar, dense cataract) which interferes with the study relevant measurements\n* Visual acuity \\< 0.1 (Snellen)'}, 'identificationModule': {'nctId': 'NCT02941406', 'briefTitle': 'MP3 (Microperimeter 3) Reproducibility in Healthy Subjects and Macular Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Reproducibility of Microperimetry Using Nidek MP3 (Microperimeter 3) in Healthy Subjects and Patients With Macular Disease - Pilot Study', 'orgStudyIdInfo': {'id': 'MP3_REP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy subjects', 'description': '* Men and Women aged 18 and older\n* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant\n* Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant'}, {'label': 'Age-related macular degeneration patients', 'description': '* Men and Women aged 18 and older\n* Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1140', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Hanusch-Krankenhaus', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Oliver Findl, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vienna Institute for Research in Ocular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vienna Institute for Research in Ocular Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}