Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 5:05 PM
Study NCT ID:
NCT03184428
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Info@eyestylianides.com', 'phone': '0035725320244', 'title': 'Christoforos Stylianides', 'organization': 'Eyestylianides ophthalmology center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'n/a All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed because no interventions were performed in the Department of Ophthalmology (only a questionnaire for information sampling was required).', 'description': "No interventions were performed in the Department of Ophthalmology (only a questionnaire for information sampling was required), thus adverse events were not monitored (including Serious Adverse Events, All-Cause-Mortality, Other Adverse Events). An investigation would have been necessary only in case of low patient's response.", 'eventGroups': [{'id': 'EG000', 'title': 'Implantation of IOL L313', 'description': 'Patients who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '2852', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '4224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implantation of IOL L313 Age<55', 'description': 'Patients age\\<55 who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.'}, {'id': 'OG001', 'title': 'Implantation of IOL L313 Age≥55', 'description': 'Patients age≥55 who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.'}], 'classes': [{'title': '1 year', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}]}]}, {'title': '2 years', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'after 4 years', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '17.2', 'groupId': 'OG001'}]}]}, {'title': 'after 6 years', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000'}, {'value': '22.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 8 years', 'description': 'In order to find out whether patients with cataract surgery are affected by lens opacification, we assessed whether a Nd:YAG laser capsulotomy was performed for treatment.\n\nFor this purpose, the patient files were spotted first. Those who had no recent findings were asked in writing if and when a laser treatment was performed. In the absence of feedback and in case of uncertain or unusable written answer, a telephone consultation with the patient was made. If sufficient information was not available afterwards, the ophthalmologist was asked for information (by phone, by written request or by collecting the data on site in the practices).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Correlation Coefficient Between Capsulotomy Rate and Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2963', 'groupId': 'OG000'}, {'value': '2852', 'groupId': 'OG001'}, {'value': '2852', 'groupId': 'OG002'}, {'value': '2929', 'groupId': 'OG003'}, {'value': '3036', 'groupId': 'OG004'}, {'value': '3017', 'groupId': 'OG005'}, {'value': '2857', 'groupId': 'OG006'}, {'value': '2990', 'groupId': 'OG007'}, {'value': '2852', 'groupId': 'OG008'}, {'value': '3784', 'groupId': 'OG009'}, {'value': '2852', 'groupId': 'OG010'}]}, {'units': 'eyes', 'counts': [{'value': '4388', 'groupId': 'OG000'}, {'value': '4224', 'groupId': 'OG001'}, {'value': '4224', 'groupId': 'OG002'}, {'value': '3944', 'groupId': 'OG003'}, {'value': '4068', 'groupId': 'OG004'}, {'value': '4088', 'groupId': 'OG005'}, {'value': '3864', 'groupId': 'OG006'}, {'value': '3906', 'groupId': 'OG007'}, {'value': '4224', 'groupId': 'OG008'}, {'value': '4049', 'groupId': 'OG009'}, {'value': '4224', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsulotomy Rate/Age', 'description': 'Correlation coefficient between capsulotomy rate and age'}, {'id': 'OG001', 'title': 'Capsulotomy Rate/Gender', 'description': 'Correlation coefficient between capsulotomy rate and gender'}, {'id': 'OG002', 'title': 'Capsulotomy Rate/Cutting Lenth', 'description': 'Correlation coefficient between capsulotomy rate and cutting length'}, {'id': 'OG003', 'title': 'Capsulotomy Rate/Core Hardness', 'description': 'Correlation coefficient between capsulotomy rate and core hardness'}, {'id': 'OG004', 'title': 'Capsulotomy Rate/Duration of Whole Operation', 'description': 'Correlation coefficient between capsulotomy rate and duration of whole operation'}, {'id': 'OG005', 'title': 'Capsulotomy Rate/Time of Phaco-emulsification', 'description': 'Correlation coefficient between capsulotomy rate and time of phaco-emulsification'}, {'id': 'OG006', 'title': 'Capsulotomy Rate/Phaco-energy', 'description': 'Correlation coefficient between capsulotomy rate and phaco-energy'}, {'id': 'OG007', 'title': 'Capsulotomy Rate/Phaco-machine', 'description': 'Correlation coefficient between capsulotomy rate and phaco-machine'}, {'id': 'OG008', 'title': 'Capsulotomy Rate/Combination With Other op', 'description': 'Correlation coefficient between capsulotomy rate and L-313 implantation in combination with other op'}, {'id': 'OG009', 'title': 'Capsulotomy Rate/Surgeon', 'description': 'Correlation coefficient between capsulotomy rate and surgeon'}, {'id': 'OG010', 'title': 'Correlation Rate/Power of IOL', 'description': 'Correlation coefficient between capsulotomy rate and power of IOL'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000'}, {'value': '0.276', 'groupId': 'OG001'}, {'value': '0.578', 'groupId': 'OG002'}, {'value': '0.041', 'groupId': 'OG003'}, {'value': '0.467', 'groupId': 'OG004'}, {'value': '0.739', 'groupId': 'OG005'}, {'value': '0.782', 'groupId': 'OG006'}, {'value': '0.746', 'groupId': 'OG007'}, {'value': '0.002', 'groupId': 'OG008'}, {'value': '0.727', 'groupId': 'OG009'}, {'value': '0.578', 'groupId': 'OG010'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010'], 'statisticalMethod': "Spearman's rank-order correlation", 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Bonferroni adjustment in addition'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 8 years', 'description': 'Correlation coefficients between capsulotomy rate and patient parameters:\n\n1. age\n2. gender,\n\n and surgical parameters:\n3. cutting length,\n4. core hardness,\n5. duration of whole operation,\n6. time of phaco-emulsification,\n7. phaco-energy,\n8. phaco-machine,\n9. combination with other operation,\n10. surgeon,\n11. power of IOL.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'L313-Implantation', 'description': 'Eyes of patients who underwent a cataract surgery in the Department of Ophthalmology in Neubrandenburg between September 2009 and December 2013 and had an L313 MICS lens.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5549', 'numSubjects': '3785'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4388', 'numSubjects': '2963'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1161', 'numSubjects': '822'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'Eyes of patients who underwent a cataract surgery in the Department of Ophthalmology in Neubrandenburg between September 2009 and December 2013 and had an L313 MICS lens implanted.', 'preAssignmentDetails': "The following reasons led to an exclusion of participants:\n\n* intraoperative posterior capsule rupture\n* Distance between place of residence and place of investigation \\>50 km\n* Exchange of the intraocular lens\n* Practice closure of the supervising ophthalmologist\n* no entry in any established doctor's medical system\n* no follow-up"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3785', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '5549', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Implantation of IOL L313', 'description': 'Patients who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the treatment for postoperative observation and survey.\n\nPostoperative observation and survey: For postoperative observation with a survey we ask the patients (or in case of no information the ophthalmologist) whether they had undergone a Nd: YAG-Laser-Capsulotomy after Cataract-Surgery or not.'}], 'measures': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3785', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '5549', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '886', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4661', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3785', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '5549', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '73.75', 'spread': '9.06', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'eyes'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3785', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '5549', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3285', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2264', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '5549', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'typeUnitsAnalyzed': 'eyes'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-15', 'size': 594939, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-29T07:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3785}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-16', 'studyFirstSubmitDate': '2017-06-09', 'resultsFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-16', 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years', 'timeFrame': 'up to 8 years', 'description': 'In order to find out whether patients with cataract surgery are affected by lens opacification, we assessed whether a Nd:YAG laser capsulotomy was performed for treatment.\n\nFor this purpose, the patient files were spotted first. Those who had no recent findings were asked in writing if and when a laser treatment was performed. In the absence of feedback and in case of uncertain or unusable written answer, a telephone consultation with the patient was made. If sufficient information was not available afterwards, the ophthalmologist was asked for information (by phone, by written request or by collecting the data on site in the practices).'}], 'secondaryOutcomes': [{'measure': 'Correlation Coefficient Between Capsulotomy Rate and Parameters', 'timeFrame': 'up to 8 years', 'description': 'Correlation coefficients between capsulotomy rate and patient parameters:\n\n1. age\n2. gender,\n\n and surgical parameters:\n3. cutting length,\n4. core hardness,\n5. duration of whole operation,\n6. time of phaco-emulsification,\n7. phaco-energy,\n8. phaco-machine,\n9. combination with other operation,\n10. surgeon,\n11. power of IOL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['YAG-Laser Capsulotomy'], 'conditions': ['Posterior Capsule Opacification']}, 'referencesModule': {'references': [{'pmid': '11237905', 'type': 'BACKGROUND', 'citation': 'Apple DJ, Peng Q, Visessook N, Werner L, Pandey SK, Escobar-Gomez M, Ram J, Auffarth GU. Eradication of posterior capsule opacification: documentation of a marked decrease in Nd:YAG laser posterior capsulotomy rates noted in an analysis of 5416 pseudophakic human eyes obtained postmortem. Ophthalmology. 2001 Mar;108(3):505-18. doi: 10.1016/s0161-6420(00)00589-3.'}, {'pmid': '10683785', 'type': 'BACKGROUND', 'citation': 'Apple DJ, Peng Q, Visessook N, Werner L, Pandey SK, Escobar-Gomez M, Ram J, Whiteside SB, Schoderbeck R, Ready EL, Guindi A. Surgical prevention of posterior capsule opacification. Part 1: Progress in eliminating this complication of cataract surgery. J Cataract Refract Surg. 2000 Feb;26(2):180-7. doi: 10.1016/s0886-3350(99)00353-3.'}, {'pmid': '15512993', 'type': 'BACKGROUND', 'citation': 'Auffarth GU, Brezin A, Caporossi A, Lafuma A, Mendicute J, Berdeaux G, Smith AF; European PCO Study Group. Comparison of Nd : YAG capsulotomy rates following phacoemulsification with implantation of PMMA, silicone, or acrylic intra-ocular lenses in four European countries. Ophthalmic Epidemiol. 2004 Oct;11(4):319-29. doi: 10.1080/09286580490515116.'}, {'pmid': '9209994', 'type': 'BACKGROUND', 'citation': 'Chitkara DK, Smerdon DL. Risk factors, complications, and results in extracapsular cataract extraction. J Cataract Refract Surg. 1997 May;23(4):570-4. doi: 10.1016/s0886-3350(97)80216-7.'}, {'pmid': '11524189', 'type': 'BACKGROUND', 'citation': 'Meacock WR, Spalton DJ, Boyce JF, Jose RM. Effect of optic size on posterior capsule opacification: 5.5 mm versus 6.0 mm AcrySof intraocular lenses. J Cataract Refract Surg. 2001 Aug;27(8):1194-8. doi: 10.1016/s0886-3350(01)00855-0.'}, {'pmid': '17372739', 'type': 'BACKGROUND', 'citation': 'Menapace R. [After-cataract following intraocular lens implantation. Part II: prevention with alternative implants and techniques]. Ophthalmologe. 2007 Apr;104(4):345-53; quiz 354-5. doi: 10.1007/s00347-007-1505-1. German.'}, {'pmid': '17323043', 'type': 'BACKGROUND', 'citation': 'Menapace R. [After-cataract following intraocular lens implantation. Part I. Genesis and prevention by optimizing conventional lens implants and surgical techniques]. Ophthalmologe. 2007 Mar;104(3):253-62; quiz 263-4. doi: 10.1007/s00347-007-1492-2. German.'}, {'pmid': '15130632', 'type': 'BACKGROUND', 'citation': 'Mester U, Fabian E, Gerl R, Hunold W, Hutz W, Strobel J, Hoyer H, Kohnen T. Posterior capsule opacification after implantation of CeeOn Edge 911A, PhacoFlex SI-40NB, and AcrySof MA60BM lenses: one-year results of an intraindividual comparison multicenter study. J Cataract Refract Surg. 2004 May;30(5):978-85. doi: 10.1016/j.jcrs.2003.09.052.'}, {'pmid': '26366054', 'type': 'BACKGROUND', 'citation': 'Nishi Y, Ikeda T, Nishi K, Mimura O. Epidemiological evaluation of YAG capsulotomy incidence for posterior capsule opacification in various intraocular lenses in Japanese eyes. Clin Ophthalmol. 2015 Sep 1;9:1613-7. doi: 10.2147/OPTH.S89966. eCollection 2015.'}, {'pmid': '15283214', 'type': 'BACKGROUND', 'citation': 'Pandey SK, Apple DJ, Werner L, Maloof AJ, Milverton EJ. Posterior capsule opacification: a review of the aetiopathogenesis, experimental and clinical studies and factors for prevention. Indian J Ophthalmol. 2004 Jun;52(2):99-112.'}, {'pmid': '12954304', 'type': 'BACKGROUND', 'citation': 'Prosdocimo G, Tassinari G, Sala M, Di Biase A, Toschi PG, Gismondi M, Corbanese U. Posterior capsule opacification after phacoemulsification: silicone CeeOn Edge versus acrylate AcrySof intraocular lens. J Cataract Refract Surg. 2003 Aug;29(8):1551-5. doi: 10.1016/s0886-3350(02)02051-5.'}, {'pmid': '9663224', 'type': 'BACKGROUND', 'citation': 'Schaumberg DA, Dana MR, Christen WG, Glynn RJ. A systematic overview of the incidence of posterior capsule opacification. Ophthalmology. 1998 Jul;105(7):1213-21. doi: 10.1016/S0161-6420(98)97023-3.'}, {'pmid': '11706380', 'type': 'BACKGROUND', 'citation': 'Schmidbauer JM, Vargas LG, Apple DJ, Auffarth GU, Peng Q, Arthur SN, Escobar-Gomez M. [Millenniums update on posterior capsule opacification (PCO) scores, centration, biocompatibility and fixation of foldable intraocular lenses (IOL) - an analysis of 1,221 pseudophakic post mortem globes]. Klin Monbl Augenheilkd. 2001 Oct;218(10):649-57. doi: 10.1055/s-2001-18386. German.'}, {'pmid': '25393894', 'type': 'BACKGROUND', 'citation': 'Schriefl SM, Leydolt C, Stifter E, Menapace R. Posterior capsular opacification and Nd:YAG capsulotomy rates with the iMics Y-60H and Micro AY intra-ocular lenses: 3-year results of a randomized clinical trial. Acta Ophthalmol. 2015 Jun;93(4):342-7. doi: 10.1111/aos.12543. Epub 2014 Nov 13.'}, {'pmid': '20234985', 'type': 'BACKGROUND', 'citation': 'Spyridaki M, Hoh H. [Comparison of four MICS intraocular lenses regarding their rates of neodymium:YAG laser capsulotomy]. Klin Monbl Augenheilkd. 2010 Mar;227(3):208-14. doi: 10.1055/s-0028-1109853. Epub 2010 Mar 16. German.'}, {'pmid': '10609214', 'type': 'BACKGROUND', 'citation': 'Tetz MR, Nimsgern C. Posterior capsule opacification. Part 2: Clinical findings. J Cataract Refract Surg. 1999 Dec;25(12):1662-74. doi: 10.1016/s0886-3350(99)00259-x.'}, {'pmid': '17384950', 'type': 'BACKGROUND', 'citation': 'Wehner W. [Microincision intraocular lens with plate haptic design. Evaluation of rotational stability and centering of a microincision intraocular lens with plate haptic design in 12-19 months of follow-up]. Ophthalmologe. 2007 May;104(5):393-4, 396-8. doi: 10.1007/s00347-007-1500-6. German.'}]}, 'descriptionModule': {'briefSummary': 'This study collects intra- and postoperative data from the patients´charts retrospectively and evaluates retro- and prospectively the rate of posterior capsule opacification (PCO) following implantation of the intraocular lens L 313.', 'detailedDescription': 'This study is a postmarket study without interventions. Within the Standard Care Cataract surgery the participants have been implanted with the intraocular lens L313 in the period between September 2009 and December 2013. As criterium for the PCO was considered the Nd:YAG capsulotomy.\n\nIn the first step of the study, data was collected from the patients´charts.\n\nIn the second phase, a questionaire was sent to the patients with no recent examination, asking them to answer whether or not participants received a laser procedure due to PCO. In doubt the participants could answer: "I am not certain". For this step the investigator ensured the positive Votum of the Ethic Committee of the University of Greifswald, Germany.\n\nOn the third step of the study, the patients that were not certain of having such a laser procedure or did not answer per post, will be contacted on telephone. By uncertainty or no answer on the telephone the family eye doctor will be contacted to receive the necessary information. If the eye doctor has lost contact to the patient, then this patient will be documented as lost-to-follow-up.\n\nExcluded were the patients that live \\>50km from the Department of Ophthalmology in Neubrandenburg, as well as patients with intraoperative capsule tear.\n\nFor the statistical analysis was used the program STATISTICA (StatSoft, Hamburg, Germany) and the survival analysis using the Kaplan-Meier formula, the statistical significance using the Chi-squared test and Spearman-Rank corelation and the Bonferroni adjustment if the test was repeated.\n\nThe investigators compared these results with the results of other publication. In order to do that the investigators calculated the capsulotomy quote from this study according to the time of the PCO recorded on the other studies. Included were only comparing studies that also used YAG-capsulotomy as criterium for the PCO.\n\nFurthermore secondary data was collected: age, gender, cutting length, core hardness, duration of whole operation, time of phaco-emulsification, phaco-energy, phaco-machine, combination with other operation, surgeon, power of IOL. This data will be taken in concern for the validity of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '3785 (5549 eyes)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* retrospective: Patients who have undergone a Cataract surgery with Implantation of IOL L313\n* prospective: signed informed consent\n\nExclusion Criteria:\n\n* capsule rupture\n* patients with too much travel distance between study center and home'}, 'identificationModule': {'nctId': 'NCT03184428', 'briefTitle': 'Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dietrich-Bonhoeffer-Klinikum'}, 'officialTitle': 'Retro- and Prospective Monocentric Study to Evaluate the Rate of Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS (Micro Incision Cataract Surgery) -IOL (Intraocular Lens) L313', 'orgStudyIdInfo': {'id': 'STN 05/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Implantation of IOL L313', 'description': 'Patients who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.', 'interventionNames': ['Other: Postoperative observation and survey']}], 'interventions': [{'name': 'Postoperative observation and survey', 'type': 'OTHER', 'description': 'For postoperative Observation with a survey we ask the patients (or in case of no information the ophthalmologist) whether they had undergone a YAG-Laser-Capsulotomy after Cataract-Surgery or not.', 'armGroupLabels': ['Implantation of IOL L313']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17036', 'city': 'Neubrandenburg', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Dietrich-Bonhoeffer-Klinikum', 'geoPoint': {'lat': 53.55735, 'lon': 13.26105}}], 'overallOfficials': [{'name': 'Helmut Hoeh, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, Neubrandenburg, Germany'}, {'name': 'Christoforos Stylianides', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Ophthalmology, Neubrandenburg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'results will be published in ophthalmological journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dietrich-Bonhoeffer-Klinikum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}