[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366390":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":76,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":26,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Preservative-free dexamethasone 0.1%\u002Fdiclofenac 0.1%","EXPERIMENTAL","One week before surgery, patients will be randomized to either receive the preservative-free dexamethasone 0.1% and diclofenac 0.1% eye drops.",[13],"Drug: Preservative Free drop treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Preserved dexamethasone 0.1%\u002Fdiclofenac 0.1%","ACTIVE_COMPARATOR","One week before surgery, patients will be randomized to either receive the preserved dexamethasone 0.1% and diclofenac 0.1% eye drops.",[19],"Drug: Preserved drop treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Preservative Free drop treatment","Patients will use the preservative-free dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Preserved drop treatment","Patients will use the preserved dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.",[15],[32],{"name":33,"affiliation":5,"role":34},"Heleen Delbeke, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+32 16 332687","heleen.delbeke@uzleuven.be",{"name":41,"role":37,"phone":38,"phoneExt":26,"email":42},"Ingeborg Stalmans, MD, PhD","ingeborg.stalmans@uzleuven.be",[44,63],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Universitaire Ziekenhuizen Leuven","RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":53,"coordinates":54},"Point",[55,56],4.70093,50.87959,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":26,"email":62},"Ingeborg Vriens","+32 16 342229","ingeborg.vriens@uzleuven.be",{"facility":64,"status":46,"city":65,"state":66,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"AZ Delta","Roeselare","West-Vlaanderen","8800",{"type":53,"coordinates":69},[70,71],3.12269,50.94653,{"lat":71,"lon":70},[74],{"name":75,"role":37,"phone":26,"phoneExt":26,"email":26},"Hilde Seynaeve, MD",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[79],{"name":80,"class":81},"Laboratoires Thea","INDUSTRY","100366390","phase-4-comparison-of-treatment-with-preservative-free-dexamethasone-01-monofree-dexamethason-and-diclofenac-01-dicloabak-eye-drops-versus-preserved-dexamethasone-01-maxidex-and-diclofenac-01-voltaren-ophtha-eye-drops-after-cataract-surgery-100366390",false,"NCT04050644","Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexamethason) and Diclofenac 0.1% (Dicloabak) Eye Drops Versus Preserved Dexamethasone 0.1% (Maxidex) and Diclofenac 0.1% (Voltaren Ophtha) Eye Drops After Cataract Surgery","GIST","Inclusion Criteria:\n\n* Patients diagnosed with age-related cataract\n* Age 60 years or above\n\nExclusion Criteria:\n\n* Unwilling to sign informed consent\n* Pseudoexfoliation syndrome\n* Functionally monocular patient\n* Any use of eye drops during at least 3 months before surgery with the exception of artificial tears\n* Pre-existing dry eye disease according to the criteria's of the TFOS DEXS II report\n* Previous ocular surgery, laser treatment or uveitis, with the exception of retinal laser treatment (more than 6 months ago) and iridotomy (more than 6 months ago)\n* Active conjunctivitis\n* Wearing of contact lens\n* Presence of any macular diseases possibly impacting visual acuity\n* Presence of any ocular diseases leading to difficulty to have a correct eye examination\n* Known or suspected allergy to any of the ingredients on the study medications\n* Presence of uncontrolled systemic disease","ALL","60 Years",{"count":92,"type":93},100,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","To compare treatment with preservative-free dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops versus preserved dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha) eye drops after cataract surgery in terms of postoperative inflammation, iatrogenic dry eye disease and cystoid macular edema.",[99],"Age-related Cataract",[101,102],"Preservative-free ocular drops","Preserved ocular drops","2024-06-28",{"date":105,"type":106},"2024-07-01","ACTUAL",{"date":108,"type":106},"2018-10-30",{"date":110,"type":93},"2024-12",{"name":5,"class":6},2]