Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 4:09 PM
Study NCT ID:
NCT01641835
Status:
COMPLETED
Last Update Posted:
2016-12-19
First Post:
2012-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optical Coherence Tomography (OCT) Data Collection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact@HeidelbergEngineering.com', 'phone': '+4962216463', 'title': 'Gerhard Zinser, PhD', 'phoneExt': '0', 'organization': 'Heidelberg Engineering GmbH'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Normals', 'description': 'No adverse events were reported.', 'otherNumAtRisk': 303, 'otherNumAffected': 0, 'seriousNumAtRisk': 303, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': 'Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve'}], 'classes': [{'title': 'peri-papillary RNFL thickness, 12mm circle scan', 'categories': [{'measurements': [{'value': '97.2', 'spread': '9.2', 'groupId': 'OG000'}]}]}, {'title': 'peri-papillary RNFL thickness, 14mm circle scan', 'categories': [{'measurements': [{'value': '83.9', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'peri-papillary RNFL thickness, 16mm circle scan', 'categories': [{'measurements': [{'value': '73.9', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': "Bruch's Membrane Opening - Minimum Rim Width, glob", 'categories': [{'measurements': [{'value': '336.1', 'spread': '51.6', 'groupId': 'OG000'}]}]}, {'title': 'Macula parameters have not been analyzed', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Posterior pole volume scans and macula volume scanshave been performed in order to allow future analysis of these data. This analysis was not performed yet and analysis is not planned at the moment.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Bruch's Membrane Opening - Minimum Rim Area, Global", 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': 'Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve'}], 'classes': [{'categories': [{'measurements': [{'value': '1339.3', 'spread': '197.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'unitOfMeasure': 'microns^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normals', 'description': 'No eye disease.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Normals', 'description': 'No eye disease.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '195', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'measurements': [{'value': '303', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects of Caucasian descent', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2012-07-13', 'resultsFirstSubmitDate': '2014-08-01', 'studyFirstSubmitQcDate': '2012-07-13', 'lastUpdatePostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-26', 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoints', 'timeFrame': '3 months', 'description': 'The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.'}, {'measure': "Bruch's Membrane Opening - Minimum Rim Area, Global", 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Collect OCT data to evaluate the range and age trend of ocular measurements.', 'detailedDescription': 'This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'No eye disease.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is not an employee of the eye clinic.\n* Age ≥18 to 90.\n* Able and willing to undergo the test procedures, give consent, and to follow instructions.\n* Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.\n* Caucasian decent (self-reported).\n* Negative history of glaucoma.\n* Intraocular pressure ≤21mmHg.\n* Best corrected visual acuity ≥0.5.\n* Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.\n* Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.\n* Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.\n* When both eyes are eligible, both eyes enter the study for inter-eye asymmetry; one randomly selected eye will be used for all other measures.\n\nExclusion Criteria:\n\n* Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.\n* Unusable disc stereo photos.\n* Inability to undergo the tests.\n* Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:\n\n * Retina completely included in image frame,\n * Quality Score ≥ 20 in the stored ART mean images, and\n * For ONH-R scan: Center position error ≤ 100 μm.\n* Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study."}, 'identificationModule': {'nctId': 'NCT01641835', 'briefTitle': 'Optical Coherence Tomography (OCT) Data Collection Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heidelberg Engineering GmbH'}, 'officialTitle': 'Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"', 'orgStudyIdInfo': {'id': 'S-2012-1 NORM-cc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normals', 'description': 'No eye disease.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Dalhousie University', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Balwantray Chauhan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dalhousie University, Halifax, NS, Canada'}, {'name': 'Claude Burgoyne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Devers Eye Institute, Portland, OR, USA'}, {'name': 'Christopher Girkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Callahan Eye Foundation Hospital, Birmingham, AL, USA'}, {'name': 'Christian Mardin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augenklinik des Universitätsklinikums Erlangen, Erlangen, Germany'}, {'name': 'Alexander Scheuerle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsaugenklinik, Heidelberg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg Engineering GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}