[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444809":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":56,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":26,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control (dexamethasone only)","ACTIVE_COMPARATOR","Topical dexamethasone 1 mg\u002Fml (Spersadex) started the day after surgery",[13],"Drug: Dexamethasone Ophthalmic",{"label":15,"type":16,"description":17,"interventionNames":18},"Study group (NSAIDs and dexamethasone)","EXPERIMENTAL","Topical nepafenac (Nevanac) 3 mg\u002Fml and dexamethasone 1 mg\u002Fml (Spersadex) started the day after surgery.",[19,13],"Drug: Nepafenac Ophthalmic",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Nepafenac Ophthalmic","Topical nepafenac (Nevanac) 3 mg\u002Fml",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Dexamethasone Ophthalmic","Topical dexamethasone 1 mg\u002Fml (Spersadex)",[9,15],[32],{"name":33,"affiliation":34,"role":35},"Olav Kristianslund, MD PhD","Department of Ophthalmology, Oslo University Hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+4722118545","olakri@ous-hf.no",[42],{"facility":34,"status":43,"city":44,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Oslo","Norway","NO",{"type":48,"coordinates":49},"Point",[50,51],10.74609,59.91273,{"lat":51,"lon":50},[54],{"name":55,"role":38,"phone":26,"phoneExt":26,"email":26},"Olav Kristianslund, PhD",{"type":35,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Olav Kristianslund","Principal investigator, Senior consultant MD PhD","100444809","phase-4-dsaekdmek-and-cystoid-macular-edema---the-role-for-topical-nsaids-nepafenac-dmec-100444809",false,"NCT05072262","DSAEK\u002FDMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)","A Randomized Clinical Two-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Postoperative Topical NSAIDs and Steroids to Only Postoperative Topical Steroids in Patients Undergoing Corneal Endothelial Transplantations (DMEC)","DMEC","Inclusion Criteria:\n\n* Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.\n* Scheduled for DSAEK or DMEK\n* Ability to cooperate fairly well during the examinations\n* Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)\n* Pregnancy or possible pregnancy during the study period\n* Preoperative macular edema and\u002For ongoing treatment for macular edema\n* Re-transplantation\n* In-operated glaucoma shunt \u002F valve (e.g. Ahmed glaucoma valve)\n* Aphakic eyes (eyes without a biological or artificial intraocular lens)\n* Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)","ALL","18 Years",{"count":70,"type":71},300,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","The DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK).",[77,78],"Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)","Descemet Membrane Endothelial Keratoplasty (DMEK)","2022-11-26",{"date":81,"type":82},"2022-12-01","ACTUAL",{"date":84,"type":82},"2022-11-25",{"date":86,"type":71},"2026-10",{"name":5,"class":6},1]