Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-05 @ 7:34 PM
Study NCT ID:
NCT02633228
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2015-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Acuity After the Combined Binocular Implantation of +2.0 Diopters and +3.0 Diopters Oculentis Multifocal Intraocular Lenses.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuities in the far, intermediate and near', 'timeFrame': '1 month', 'description': 'Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).'}, {'measure': 'Visual acuities in the far, intermediate and near', 'timeFrame': '3 months', 'description': 'Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).'}, {'measure': 'Mesopic vision', 'timeFrame': '1 month', 'description': 'Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.'}, {'measure': 'Mesopic vision', 'timeFrame': '3 months', 'description': 'Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.'}, {'measure': 'Scotopic contrast sensitivity', 'timeFrame': '1 month', 'description': 'Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.'}, {'measure': 'Scotopic contrast sensitivity', 'timeFrame': '3 months', 'description': 'Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.'}], 'secondaryOutcomes': [{'measure': 'Spectacle independence in the far, intermediate and near', 'timeFrame': '3 months', 'description': 'Spectacle independence as stated by the patient.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multifocal Intraocular Lens', 'Binocular Trifocality', 'Cataract Surgery', 'Spectacle Independence', 'Intermediate Vision', 'Photopic Vision', 'Mesopic Vision', 'Scotopic Vision', 'Binocular Vision'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '23557223', 'type': 'BACKGROUND', 'citation': 'Alio JL, Plaza-Puche AB, Javaloy J, Ayala MJ, Vega-Estrada A. Clinical and optical intraocular performance of rotationally asymmetric multifocal IOL plate-haptic design versus C-loop haptic design. J Refract Surg. 2013 Apr;29(4):252-9. doi: 10.3928/1081597X-20130318-04.'}, {'pmid': '26469073', 'type': 'BACKGROUND', 'citation': 'Bonaque-Gonzalez S, Rios S, Amigo A, Lopez-Gil N. Influence on Visual Quality of Intraoperative Orientation of Asymmetric Intraocular Lenses. J Refract Surg. 2015 Oct;31(10):651-7. doi: 10.3928/1081597X-20150922-01.'}, {'pmid': '25884577', 'type': 'BACKGROUND', 'citation': 'Garcia-Domene MC, Felipe A, Peris-Martinez C, Navea A, Artigas JM, Pons AM. Image quality comparison of two multifocal IOLs: influence of the pupil. J Refract Surg. 2015 Apr;31(4):230-5. doi: 10.3928/1081597X-20150319-02.'}, {'pmid': '22496436', 'type': 'BACKGROUND', 'citation': 'Alio JL, Plaza-Puche AB, Pinero DP. Rotationally asymmetric multifocal IOL implantation with and without capsular tension ring: refractive and visual outcomes and intraocular optical performance. J Refract Surg. 2012 Apr;28(4):253-8. doi: 10.3928/1081597X-20120314-01.'}, {'pmid': '22373031', 'type': 'BACKGROUND', 'citation': 'Munoz G, Albarran-Diego C, Javaloy J, Sakla HF, Cervino A. Combining zonal refractive and diffractive aspheric multifocal intraocular lenses. J Refract Surg. 2012 Mar;28(3):174-81. doi: 10.3928/1081597X-20120215-02.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses.', 'detailedDescription': "Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically significant cataract\n* endothelial cell count: patients aged 18-75 years: \\> 1000 cells/mm2; patients \\> 75 years: \\> 750 cells/mm2\n* absence of vision-limiting corneal or retinal comorbidities\n* capability to understand the informed consent\n\nExclusion Criteria:\n\n* expected postoperative astigmatism \\> 0.75 diopters\n* irregular astigmatism\n* dilated pupil diameter \\< 3 mm\n* corneal and fundus abnormalities that might cause visual impairments\n* inability to attend follow-up visits'}, 'identificationModule': {'nctId': 'NCT02633228', 'briefTitle': 'Visual Acuity After the Combined Binocular Implantation of +2.0 Diopters and +3.0 Diopters Oculentis Multifocal Intraocular Lenses.', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Evaluation of the Visual Acuity After the Implantation of an Oculentis +2.0 Diopters (Torical) Bifocal Intraocular Lens (MplusX (Toric) LU-313 MF20T/LS-313 MF20) in the Distance Dominant Eye, in Combination With a +3.0 Diopters Oculentis Bifocal Intraocular Lens (MplusX (Toric) LU-313 MF30T/LS-313 MF30) in the Fellow Eye.', 'orgStudyIdInfo': {'id': 'EA2/129/14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses', 'type': 'DEVICE', 'otherNames': ['Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D (LU-313 MF20T/LS-313 MF20) and +3.0 D (LU-313 MF30T/LS-313 MF30) are used.'], 'description': 'Binocular implantation of the combination of Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D in the distance-dominant eye and +3.0 D in the fellow eye.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - University Medicine Berlin, Department of Ophthalmology', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Eckart Bertelmann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - University Medicine Berlin, Department of Ophthalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PD Dr. med. Eckart Bertelmann', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'PD Dr. med. Eckart Bertelmann', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}