Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-02 @ 6:38 AM
Study NCT ID:
NCT03832335
Status:
UNKNOWN
Last Update Posted:
2019-02-06
First Post:
2019-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Measurement of Anseikonia Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000839', 'term': 'Aniseikonia'}, {'id': 'D015858', 'term': 'Anisometropia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2019-01-31', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aniseikonia tolerance', 'timeFrame': 'baseline', 'description': 'How many percent aniseikonia is tolerated before stereopsis is impaired. Measured by first measuring baseline stereopsis and here after adding aniseikonic (size glass) from 1-9% in front of the right and left eye to measure if stereopsis is impaired. If stereopsis is impaired at 4% sizeglas then aniseikonia tolerance is 4%.'}, {'measure': 'Change of Aniseikonia tolerance after surgery', 'timeFrame': 'six weeks after surgery', 'description': 'Measurement of aniseikonia tolerance before and after surgery. Measurement: before and after surgery stereopsis is measured, hereafter aniseikonic glasses (size glass) from 1-9% is added in front of the right and left eye to see if stereopsis is impaired. If stereopsis is impaired with 3% aniseikonic glass then the tolerance is 3%. After surgery the measurement is repeated to examine if the aniseikonia tolerance is the same.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aniseikonia', 'Anisometropia and Aniseikonia']}, 'descriptionModule': {'briefSummary': 'Population 1:\n\nMeasure the effect of size glasses from1-9% on stereopsis\n\nPopulation 2:\n\nMeasure the effect of size glasses from 1-9% on stereopsis in two settings:\n\n* before and after cataract surgery\n* after dilation of the eye', 'detailedDescription': 'Population 1:\n\n21 eye healthy phakic individuals. Measurements: baseline stereopsis and stereopsis after size glass (1-9%) is added in front of the right eye and in front og the left eye. This measurement provides details on how much size difference a person can endure without impairing stereopsis.\n\nPopulation 2:\n\n11 phakic eye healthy individuals awaiting cataract operation on both eyes. Measurements are the same as population 1 but this study group is also measured after dilating the eyes. This is to see if accommodation affects the measurement. A postoperative measurement six weeks after cataract operation is also performed to examine if cataract operation affects the measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'group 1: eyehealthy pahkic individuls group 2: eyehalthy phakic patients awainting cataratc surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No previous eye history\n* cataract grade \\<= 1\n* visual acuity above 0.8\n\nExclusion Criteria:\n\n* lack of cooperation\n* amblyopia\n* axial anisometropia\n* ametropia'}, 'identificationModule': {'nctId': 'NCT03832335', 'briefTitle': 'A New Measurement of Anseikonia Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Can we Measure Aniseikonia Tolerance in a Normal Population', 'orgStudyIdInfo': {'id': '04127'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phakic group', 'description': '21 eyehealthy individuals examined for baseline stereopsis and impact of aniseikonia on stereopsis. An non-invasive measurement.', 'interventionNames': ['Diagnostic Test: Measurement of aniseikonia tolerance']}, {'label': 'Cataract group', 'description': '11 patients awaiting cataract surgery on both eyes. Measurement of baseline stereopsis and impact of artificial induced aniseikonia on stereopsis. A non invasive measurement that are repeated after dilatation of the eyes and again six weeks after surgery.', 'interventionNames': ['Diagnostic Test: Measurement of aniseikonia tolerance']}], 'interventions': [{'name': 'Measurement of aniseikonia tolerance', 'type': 'DIAGNOSTIC_TEST', 'description': 'Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis', 'armGroupLabels': ['Cataract group', 'Phakic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'state': 'Danmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Therese Krarup, MD', 'role': 'CONTACT', 'email': 'theresekrarup@gmail.com', 'phone': '+4528577271'}, {'name': 'Birgit Sander', 'role': 'CONTACT', 'email': 'bisan@regionh.dk', 'phone': '+4538633863'}], 'facility': 'Rigshospitalet-glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Therese Krarup', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}