Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
Study NCT ID:
NCT03452969
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity at far distance', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Monocular and binocular corrected visual acuity at far distance measured in logMAR 3 month after lens surgery'}], 'secondaryOutcomes': [{'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'}, {'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 with the Functional Acuity Contrast Test (FACT) chart in the Optec 6500 Vision Tester (Stereo Optical Co., Chicago, IL) under binocular photopic (85 cd/m²), mesopic (3 cd/m²), and photopic and mesopic with glare conditions at a spatial frequency of 6 cycles per degree (cpd) (threshold range 0.78-2.26).'}, {'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).'}, {'measure': 'Radner reading skills', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Binocular distance-corrected reading acuity (40 cm) was investigated in LogRAD (Reading Acuity Determination) using reading charts (Radner Reading Charts).'}, {'measure': 'Optical quality questionnaire', 'timeFrame': 'Measured 3 month after lens surgery', 'description': 'Quality of vision questionnaire (visual analogue scale (VAS) 0 (perfect / no symptoms) to 100 (extremely poor / maximum symptom intensity)) asking for evaluation of "glare", "halos", "starbursts", "blurred vision", and "ghosting" under photopic, mesopic and scotopic light conditions, if they wear any spectacles, and to evaluate their total quality of vision.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['visual outcomes', 'mulitfocal intraocular lens', 'patient satisfaction', 'spectacle independence', 'contrast sensitivity'], 'conditions': ['Visual Acuity']}, 'descriptionModule': {'briefSummary': 'To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.', 'detailedDescription': 'Purpose: This prospective, nonrandomized noncomparative case series investigates the visual performance after bilateral implantation of a segmental refractive multifocal intraocular lenses (IOL) after cataract surgery and was performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.\n\nMethods: Fifty eyes (25 patients) were included. Inclusion criteria were bilateral cataract, age \\> 45 years, corneal astigmatism ≤ 0.75 D postoperatively, pupil size 3 to 6 mm (mesopic), and center shift \\< 1 mm (Pentacam). Exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (DCVA) \\< 0.3 logMAR,\n\nIntervention or Observation: Uncorrected (UCVA) and DCVA in 4 m, 80 cm, 40 cm; contrast sensitivity (CS) under photopic and mesopic conditions; reading skills (Radner Reading Charts); defocus curve, questionnaire on optical quality (OQ) and spectacle independence were assessed after 3 months.\n\nMain Outcome Measures: At 3 months postoperatively, UCVA and DCVA in 4 m, 80 cm, 40 cm (logMAR); defocus curves; CS; reading skills; and OQ questionnaire results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received bilateral cataract surgery with the implantation of a segmental refractive multifocal intraocular lens', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral cataract\n* age \\> 45 years\n* corneal astigmatism ≤ 0.75 D postoperatively\n* pupil size 3 to 6 mm (mesopic)\n* center shift \\< 1 mm\n\nExclusion Criteria:\n\n* previous ocular surgeries\n* amblyopia\n* potential postoperative distance-corrected visual acuity (DCVA) \\< 0.3 logMAR'}, 'identificationModule': {'nctId': 'NCT03452969', 'briefTitle': 'Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens', 'organization': {'class': 'OTHER', 'fullName': 'University Clinic Frankfurt'}, 'officialTitle': 'Visual Outcomes After Implantation of a Segmental Refractive Multifocal Intraocular Lens Following Cataract Surgery', 'orgStudyIdInfo': {'id': '153/14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implantation of multifocal intraocular lens', 'type': 'OTHER', 'description': 'Procedure/Surgery:\n\nBilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.'}]}, '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': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University Clinic Frankfurt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Clinic Frankfurt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oculentis GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med. Thomas Kohnen', 'investigatorFullName': 'Myriam Böhm, MD', 'investigatorAffiliation': 'University Clinic Frankfurt'}}}}