Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT02177669
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2014-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Test-Retest Variability of Quick Contrast Sensitivity Function Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2014-06-26', 'studyFirstSubmitQcDate': '2014-06-27', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '95% coefficient of repeatability across subjects', 'timeFrame': 'test-retest at 2 visits about a week apart', 'description': 'We will evaluate various contrast sensitivity metrics that are generated by the computer program: (i) AULCSF or area under the curve for the log contrast sensitivity function (CSF), (ii) CSF acuity or the cutoff-frequency at which sensitivity=2.0 is calculated, and (iii) contrast sensitivity at various spatial frequencies (i.e. 1.5, 3, 6, 12, 18.5 cycles per degree), obtained with testing performed binocularly, with the better eye monocularly, and with the better eye using a NoIR 4% transmission filter. Within subject, the data will be analyzed as differences between the two values obtained at the two sessions, which can then be used to determine a 95% coefficient of repeatability across subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Normal, healthy individuals without ocular disease', 'Ages 20-89', 'English speaking', 'Visual acuity better than 20/25'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '24114545', 'type': 'BACKGROUND', 'citation': 'Dorr M, Lesmes LA, Lu ZL, Bex PJ. Rapid and reliable assessment of the contrast sensitivity function on an iPad. Invest Ophthalmol Vis Sci. 2013 Nov 5;54(12):7266-73. doi: 10.1167/iovs.13-11743.'}, {'pmid': '20377294', 'type': 'BACKGROUND', 'citation': 'Lesmes LA, Lu ZL, Baek J, Albright TD. Bayesian adaptive estimation of the contrast sensitivity function: the quick CSF method. J Vis. 2010 Mar 30;10(3):17.1-21. doi: 10.1167/10.3.17.'}]}, 'descriptionModule': {'briefSummary': 'The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial vision and predicts functional vision better than visual acuity, but long testing times prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al. (2010) developed the qCSF method to obtain precise CSF measurements in only 30-50 trials using a computerized software program that presents letters on a large monitor that are identified by a patient similar to typical visual acuity testing with an eye chart. The quick CSF method is a Bayesian adaptive method that estimates the full shape of the CSF, and the test duration is only about 3-6 minutes. Some preliminary testing has been performed at other sites with this test in patients with vision loss due to amblyopia and glaucoma, but data from individuals without eye disease who have normal visual acuity has not been systematically collected with the latest version of this test procedure across a wide range of ages. In addition, we aim to gain a better understanding of the typical test-retest variability that is obtained between-sessions that are about a week apart from individuals with good ocular health and visual acuity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Individuals between the ages of 20-89 without ocular disease will be recruited from among patients seen in the Primary Eye Care Clinic at the Nova Southeastern University's The Eye Care Institute in Davie-Ft. Lauderdale, FL, as well as faculty, students and staff at this institution.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 20-89\n* Normal distance visual acuity in each of both eyes (20/20)\n* Absence of ocular disease\n* Able and willing to complete contrast sensitivity testing\n* Provide informed consent\n\nExclusion Criteria:\n\n* Any ocular disease\n* Refractive errors \\>6D\n* Inability to understand study or communicate responses (cognitive impairment)\n* Unable to understand, read and speak English fluently'}, 'identificationModule': {'nctId': 'NCT02177669', 'briefTitle': 'Test-Retest Variability of Quick Contrast Sensitivity Function Testing', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'orgStudyIdInfo': {'id': '05291468Exp'}, 'secondaryIdInfos': [{'id': 'R21EY023720', 'link': 'https://reporter.nih.gov/quickSearch/R21EY023720', 'type': 'NIH'}, {'id': 'Adaptive Sensory Technology', 'type': 'OTHER_GRANT', 'domain': 'Adaptive Sensory Technology'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normals without ocular disease', 'interventionNames': ['Other: quick Contrast Sensitivity Function test']}], 'interventions': [{'name': 'quick Contrast Sensitivity Function test', 'type': 'OTHER', 'armGroupLabels': ['Normals without ocular disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33328', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Southeastern University; College of Optometry', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}], 'overallOfficials': [{'name': 'Ava K Bittner, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Southeastern University; College of Optometry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Adaptive Sensory Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}