Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-13 @ 9:02 AM
Study NCT ID:
NCT03223857
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Visual Performance After Bilateral Implantation of Multifocal Intraocular Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-22', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity at intermediate distance', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity at far distance', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Monocular and binocular best corrected visual acuity at far distance measured in logMAR 3 month after lens surgery'}, {'measure': 'Best corrected visual acuity at near distance', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery'}, {'measure': 'Uncorrected visual acuity at far distance', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery'}, {'measure': 'Uncorrected visual acuity at intermediate distance', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery'}, {'measure': 'Uncorrected visual acuity at near distance', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery'}, {'measure': 'Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Binocular contrast sensitivity (CS) was measured under photopic, mesopic (0.167 cd/m²), and mesopic with glare lighting conditions by means of the "Frankfurt-Freiburg Contrast and Acuity Test System" (FF-CATS)'}, {'measure': 'Defocus curve testing', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Defocus curve (monocular and binocular) was tested from -5.0 D to +2.0 D in 0.5 D steps under photopic lighting conditions (ETDRS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['visual outcomes', 'multifocal intraocular lens', 'patient satisfaction', 'spectacle independence'], 'conditions': ['Visual Acuity']}, 'descriptionModule': {'briefSummary': 'To evaluate the visual performance after bilateral implantation of multifocal intraocular lenses.', 'detailedDescription': 'This study evaluates the visual performance after bilateral implantation of multifocal intraocular lenses (IOL). This prospective study is performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.\n\nPatients who received bilateral implantation of a multifocal intraocular lens pre-enrollment were included consecutively. Exclusion criteria were previous ocular surgeries excluding cataract surgery and refractive lens exchange, regular corneal astigmatism of \\>1.5 diopter, and ocular pathologies or corneal abnormalities. At 3 months postoperative examination included manifest refraction; monocular and binocular uncorrected (UCVA) and distance-corrected (DCVA) visual acuity in at far, intermediate at near distance (logMAR); slit-lamp examination. 3 months postoperatively defocus testing, binocular contrast sensitivity (CS) under photopic and mesopic conditions, and a questionnaire on subjective quality of vision, optical phenomena, and spectacle independence were performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received bilateral cataract surgery or refractive lens exchange with the implantation of a multifocal intraocular lens', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral cataract surgery or refractive lens exchange with the implantation a multifocal intraocular lens\n* a regular corneal astigmatism \\< 1.5 D measured with Pentacam (Oculus, Wetzlar, Germany)\n\nExclusion Criteria:\n\n* other previous ocular surgeries\n* ocular pathologies\n* corneal abnormalities\n* endothelial cell count below 2000/mm²'}, 'identificationModule': {'nctId': 'NCT03223857', 'briefTitle': 'To Evaluate the Visual Performance After Bilateral Implantation of Multifocal Intraocular Lenses', 'organization': {'class': 'OTHER', 'fullName': 'University Clinic Frankfurt'}, 'officialTitle': 'Visual Performance of Multifocal Intraocular Lenses Following Removal of the Crystalline Lens', 'orgStudyIdInfo': {'id': '102/13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Femtosecond-laser-assisted lens exchange', 'type': 'PROCEDURE', 'description': 'Bilateral implantation of multifocal intraocular lens (MIOL) following femtosecond-laser-assisted lens exchange'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Department of ophthalmology University clinic Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Thomas Kohnen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Goethe University Clinic Frankfurt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Clinic Frankfurt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med. Thomas Kohnen', 'investigatorFullName': 'Myriam Böhm, MD', 'investigatorAffiliation': 'University Clinic Frankfurt'}}}}