Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-29 @ 12:50 AM
Study NCT ID:
NCT04255732
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Wide-field Retinal Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-03', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in retinal periphery viewing between the two devices', 'timeFrame': '7 months', 'description': 'Extent of retinal periphery area viewing (the difference in periphery area between the two devices). Images of the same patients will be compared to determine the degree of periphery viewing for the two devices.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retinal imaging', 'wide field'], 'conditions': ['Retinal Disease']}, 'descriptionModule': {'briefSummary': 'Fundus imaging has become an integral tool in retinal diagnosis. Although single-field fundus photography covers a vital region of the retina, it leaves a large portion of the periphery undiscovered.\n\nUltra-wide-field imaging systems allowed for visualization of peripheral perfusion abnormalities in myopic eyes that were previously unknown.\n\nIn Austria, there are two different wide-field imaging systems available. The first device on the market was the Optos (Optos PLC, Dunfermline, UK) and several years later the Clarus 500 (Carl Zeiss, Meditec AG, Jena, Germany) was introduced.', 'detailedDescription': 'While both of the studied imaging systems have the possibility of a 200° view of the retina, we would asses if the differences between the two devices affect the extent of retinal periphery view and if ocular ametropies which come with different retinal pathologies would affect the retinal periphery assessment.\n\nAim: To compare two CE-marked imaging systems concerning the extent of retinal periphery area viewing.\n\nWe would like to perform a prospective observational study that would include patients divided into three groups: myopic patients, hyperopic and emmetropic patients.\n\nFundus photography will be performed using two ultra-wide-field imaging systems (Optos, Daytona, Optos PLC, Dunfermline, UK and Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany), performed by the same investigator.\n\nAll images with sufficient quality will be exported and saved to hard-disk. The difference in periphery view will be investigated as follows: two retinal photos for each patient will be imported into Photoshop CS6 image-editing system (Adobe, version 13.0.0) where the anatomical landmarks will be matched for each image and the borders will be compared to see if there are differences in retinal periphery area viewing between the two devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 21 years old\n* Myopic (at least -5.00Dsph), hyperopic (over +3.00Dsph) and emmetropic patients\n* Written informed consent prior to any study specific action.\n\nExclusion Criteria:\n\n* Extensive cataract or severe corneal scaring that would affect image quality\n* Fixation problems, nystagmus\n* pregnancy- for women in reproductive age a pregnancy test will be performed.'}, 'identificationModule': {'nctId': 'NCT04255732', 'briefTitle': 'Comparison of Wide-field Retinal Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Comparison Between Two Wide-field Imaging Systems on the Extent of Retinal Periphery Area Viewing', 'orgStudyIdInfo': {'id': 'UWF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Extent of retinal periphery area viewing', 'description': 'For the 30 patients fundus photography will be performed using two ultra-wide-field imaging systems.', 'interventionNames': ['Device: extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK', 'Device: extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany']}], 'interventions': [{'name': 'extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK', 'type': 'DEVICE', 'description': 'Comparison of the extent of retinal periphery view between two wide field imaging devices.', 'armGroupLabels': ['Extent of retinal periphery area viewing']}, {'name': 'extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany', 'type': 'DEVICE', 'description': 'Comparison of the extent of retinal periphery view between two wide field imaging devices.', 'armGroupLabels': ['Extent of retinal periphery area viewing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Oliver Findl, MD, Prof', 'role': 'CONTACT', 'email': 'oliver@findl.at', 'phone': '+43 1 91021-84611'}], 'facility': 'Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Oliver Findl, Prof.', 'role': 'CONTACT', 'email': 'oliver@findl.at', 'phone': '+43 1 91021-84611'}, {'name': 'Nino Hirnschall, MD, PhD', 'role': 'CONTACT', 'email': 'nino@hirnschall.at', 'phone': '+43 1 91021-84611'}], 'overallOfficials': [{'name': 'Oliver Findl, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VIROS, Hanusch Hospital Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prim. Prof. Dr. Oliver Findl, MBA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Ophthalmology Department, principal investigator', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}