Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT06978556
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photopic and Mesopic Multifocal IOL Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2025-05-11', 'studyFirstSubmitQcDate': '2025-05-11', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOL axial position stability', 'timeFrame': '1, 3, 6, 12 months', 'description': 'as measured with a biometry and/or anterior segment device.'}], 'secondaryOutcomes': [{'measure': 'refraction', 'timeFrame': '1, 3, 6, 12 months', 'description': 'standardized ETDRS charts Optometrist blinded'}, {'measure': 'Visual acuity', 'timeFrame': '1, 3, 6, 12 months', 'description': 'Standardized with ETDRS charts for far, intermediate, and far distance visual acuity. Defocus curve.\n\nOptometris is blinded. Measurement in photopic and mesopic conditions'}, {'measure': 'Reading speed', 'timeFrame': '3 months', 'description': 'standardized with iRest test. In photopic and mesopic conditions.\n\noptometrist is blinded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract', 'multifocal iol', 'presbyopia', 'reading speed'], 'conditions': ['Cataract', 'Presbyopia Correction']}, 'referencesModule': {'references': [{'pmid': '35858191', 'type': 'BACKGROUND', 'citation': 'Benyoussef AA, Reboux N, Cochener B. Comparison of Bilateral Reading Performance Among Two Presbyopia-Correcting Intraocular Lenses. J Refract Surg. 2022 Jul;38(7):428-434. doi: 10.3928/1081597X-20220516-02. Epub 2022 Jul 1.'}, {'pmid': '31185099', 'type': 'BACKGROUND', 'citation': 'Seiler TG, Wegner A, Senfft T, Seiler T. Dissatisfaction After Trifocal IOL Implantation and Its Improvement by Selective Wavefront-Guided LASIK. J Refract Surg. 2019 Jun 1;35(6):346-352. doi: 10.3928/1081597X-20190510-02.'}, {'pmid': '23953097', 'type': 'BACKGROUND', 'citation': 'Cillino G, Casuccio A, Pasti M, Bono V, Mencucci R, Cillino S. Working-age cataract patients: visual results, reading performance, and quality of life with three diffractive multifocal intraocular lenses. Ophthalmology. 2014 Jan;121(1):34-44. doi: 10.1016/j.ophtha.2013.06.034. Epub 2013 Aug 14.'}, {'pmid': '25661129', 'type': 'BACKGROUND', 'citation': 'Marques EF, Ferreira TB. Comparison of visual outcomes of 2 diffractive trifocal intraocular lenses. J Cataract Refract Surg. 2015 Feb;41(2):354-63. doi: 10.1016/j.jcrs.2014.05.048.'}, {'pmid': '27375069', 'type': 'BACKGROUND', 'citation': 'Martinez-de-la-Casa JM, Carballo-Alvarez J, Garcia-Bella J, Vazquez-Molini JM, Morales L, Sanz-Fernandez JC, Polo V, Garcia-Feijoo J. Photopic and Mesopic Performance of 2 Different Trifocal Diffractive Intraocular Lenses. Eur J Ophthalmol. 2017 Jan/Feb;27(1):26-30. doi: 10.5301/ejo.5000814.'}, {'pmid': '29044974', 'type': 'BACKGROUND', 'citation': 'Alio JL, Kaymak H, Breyer D, Cochener B, Plaza-Puche AB. Quality of life related variables measured for three multifocal diffractive intraocular lenses: a prospective randomised clinical trial. Clin Exp Ophthalmol. 2018 May;46(4):380-388. doi: 10.1111/ceo.13084. Epub 2017 Nov 29.'}, {'pmid': '22018367', 'type': 'BACKGROUND', 'citation': 'Portney V. Light distribution in diffractive multifocal optics and its optimization. J Cataract Refract Surg. 2011 Nov;37(11):2053-9. doi: 10.1016/j.jcrs.2011.04.038.'}, {'pmid': '33577276', 'type': 'BACKGROUND', 'citation': 'Hienert J, Hirnschall N, Ruiss M, Ullrich M, Zwickl H, Findl O. Prospective study to compare axial position stability after fellow-eye implantation of 2 distinct intraocular lens designs. J Cataract Refract Surg. 2021 Aug 1;47(8):999-1005. doi: 10.1097/j.jcrs.0000000000000557.'}]}, 'descriptionModule': {'briefSummary': 'Modern cataract surgery has become a refractive procedure. Both, multifocal lens implantation and pseudophakic monovision with monofocal IOLs are effective means to address presbyopia correction after cataract surgery. Historically, diffractive multifocal IOLs have provided improved visual acuity at near and intermediate distances and a greater likelihood of spectacle independence than monofocal IOLs.\n\nThe light transmittance ratio of the crystalline lens is high and as a monofocal ocular medium that has the ability to modify its shape and geometric properties according to the focal point. Therefore, it is capable of delivering the exact same light energy to the retina, regardless of the distance of the object. Trifocal IOL designs split the light in three focal points. By varying the height of the diffractive step, the amount of light distributed to near, intermediate and distant foci is adjusted according to pupil aperture. The distribution of light to three different foci includes several potential disadvantages, such as loss of visual acuity in mesopic conditions and a loss of contrast sensitivity. Thus, the visual performance of multifocal IOLs depends on several factors, the addition (add) power is a major determinant of the actual range of clear vision, another factor is the light transmittance characteristics of the lens (e.g., the incorporation of a blue light filter).\n\nAs different trifocal IOLs become available, it is important to have information on their characteristics regarding visual acuity in order to be able to recommend an IOL that meets the individualized needs of each patient. In order to provide the patient with a high visual acuity in all promised distances, these IOLs need to be aimed at and achieve emmetropia.\n\nFurthermore, multifocal IOLs need good capsular bag centration, they need to remain as unaffected as possible by capsular bag constriction and remain stable in their axial lens position in order to provide a stable refraction after surgery.\n\nThe investigators compare the anterior chamber depth stability as marker for positional stability and haptic buckling between two different diffractive IOL designs, one with C-loop haptics and one with plate haptics. Furthermore, the refractive outcome of these IOLs with different designs is examined in photopic and mesopic conditions, as well as visual acuity results for both IOLs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing cataract surgery with multifocal IOL implantation at the study site fulfilling inclusion criteria will be asked to participate in the study. All patients are referred by ophthalmologists or are self-referrals at the study site.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects age 45 years of age and older\n2. Able to provide written informed consent and follow study instructions in English or German.\n3. Desire for spectacle independence\n4. Agreement on clinical decision for planned crystalline lens exchange with multifocal IOL implantation (Standardized femtosecond-laser capsulotomy (diameter 5.3mm))\n5. Willing and able to return for scheduled follow-up examinations;\n\nExclusion Criteria:\n\n1. Prior ophthalmic surgery or trauma\n2. Zonular-defects, unstable bag\n3. Macular pathologies\n4. Excessive irregular astigmatism\n\n6\\. Pregnancy/lactation 7. Predicted Visual acuity of less than 0.8 decimal 8. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;'}, 'identificationModule': {'nctId': 'NCT06978556', 'acronym': 'MIOLRead', 'briefTitle': 'Photopic and Mesopic Multifocal IOL Performance', 'organization': {'class': 'OTHER', 'fullName': 'IROC AG'}, 'officialTitle': 'Comparison of Lens Position and Photopic and Mesopic Visual Acuity After Bilateral Implantation of Two Different Diffractive Multifocal Intraocular Lenses.', 'orgStudyIdInfo': {'id': 'EMEA202102'}, 'secondaryIdInfos': [{'id': 'IE9970584V', 'type': 'OTHER_GRANT', 'domain': 'AMO IRELAND, Co. Dublin, Ireland'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multifocal IOL 1', 'description': 'bilateral pseudophakia with multifocal IOL 1 (Johnson and Johnson Synergy)', 'interventionNames': ['Diagnostic Test: No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.']}, {'label': 'Multifocal IOL 2', 'description': 'bilateral pseudophakia with multifocal IOL 2 (Carl Zeiss Meditec AT Lisa Tri)', 'interventionNames': ['Diagnostic Test: No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.']}], 'interventions': [{'name': 'No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.', 'type': 'DIAGNOSTIC_TEST', 'description': 'No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated. Including data from testing refraction, visual acuity, biometry, tomography, and OCT.', 'armGroupLabels': ['Multifocal IOL 1', 'Multifocal IOL 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8002', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'IROC', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Theo Seiler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IROC AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IROC AG', 'class': 'OTHER'}, 'collaborators': [{'name': 'AMO Ireland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Dr. rer. nat.', 'investigatorFullName': 'Theo Seiler', 'investigatorAffiliation': 'IROC AG'}}}}