Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT03479827
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring the Peripheral Optical Quality of The Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-12', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Wavefront aberrations', 'timeFrame': 'less than 2 hours', 'description': 'The scanning wavefront sensor will be used to collect data. Mean Wavefront aberrations for each trail will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Nearsightedness']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to quantify wavefront aberration profiles of the eye with and without contact lens across the visual field. This will enable us to investigate the impact of the aberration on retinal image quality.', 'detailedDescription': 'The goal of this study is to investigate the effects of monofocal and bifocal soft contact lenses in the changes of peripheral optical quality and through-focus visual performance on real eyes. The goal will be accomplished by performing optical measurements using Shack-Hartmann wavefront sensor with and without the use of single vision and bifocal soft contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with no ocular pathology and uses contact lenses.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nA person will be included in the study if he/she:\n\n* Is 18 years or older and has full legal capacity to volunteer.\n* Has no ocular condition or pathology, which may impact visual acuity e.g. keratoconus, amblyopia, cataract, macular degeneration;\n* Has no active ocular disease or allergic conjunctivitis;\n* Is not using any topical ocular medications;\n* Is willing and able to follow instructions;\n* Has voluntarily agreed to participate in the study by signing the statement of informed consent.\n\nExclusion Criteria\n\nA person will be excluded from the study if he/she:\n\n* Is under the age of 18 or over the age of 60 yrs.\n* Correctable with high contrast logMAR acuity (EDTRS) testing to 20/20 or better;\n* Pregnant at the time of enrolment in the study;\n* Unable to handle, insert, remove or care for the study lenses;\n* Considered by the Investigator to not be a suitable candidate for participation.'}, 'identificationModule': {'nctId': 'NCT03479827', 'briefTitle': 'Measuring the Peripheral Optical Quality of The Eye', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Measuring the Peripheral Optical Quality of The Eye', 'orgStudyIdInfo': {'id': '71201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Subjects will undergo three Wavefront measurements, once with no contact lens, once with a monofocal contact lens and once with a bifocal contact lens.', 'interventionNames': ['Device: Monofocal Contact Lens', 'Device: Bifocal Contact Lens']}], 'interventions': [{'name': 'Monofocal Contact Lens', 'type': 'DEVICE', 'description': 'A monofocal contact lens will be used for this measurement.', 'armGroupLabels': ['Experimental']}, {'name': 'Bifocal Contact Lens', 'type': 'DEVICE', 'description': 'A bifocal contact lens will be used for this measurement.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14627', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Geunyoung Yoon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Geunyoung Yoon', 'investigatorAffiliation': 'University of Rochester'}}}}