[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613346":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":63,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Instituto Ramón y Cajal de Investigación Sanitaria","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FECD Cohort",null,"Patients with clinically diagnosed Fuchs endothelial corneal dystrophy (FECD) undergoing phacoemulsification cataract surgery at participating tertiary centers. All participants receive standard cataract surgery, and their preoperative data are used to calculate the SUCCESS Score with and without corneal densitometry parameters. Postoperative outcomes are monitored to determine the need for endothelial keratoplasty (EK).",[13],"Procedure: Phacoemulsification Cataract Surgery",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Phacoemulsification Cataract Surgery","Standard phacoemulsification cataract surgery performed in patients with Fuchs endothelial corneal dystrophy (FECD). All procedures are carried out according to institutional protocols at participating tertiary centers. Preoperative Scheimpflug tomography and corneal densitometry measurements are collected to calculate the SUCCESS Score and evaluate the risk of postoperative endothelial decompensation. Postoperative outcomes are monitored to determine whether endothelial keratoplasty (EK) is required during follow-up.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Francisco Arnalich-Montiel, PhD","CONTACT","+34 913368853","francisco.arnalich@salud.madrid.org",[27],{"facility":28,"status":29,"city":30,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)","RECRUITING","Madrid","28034","Spain","ES",{"type":35,"coordinates":36},"Point",[37,38],-3.70256,40.4165,{"lat":38,"lon":37},[41,43],{"name":42,"role":23,"phone":24,"phoneExt":10,"email":25},"Francisco Arnalich Montiel, PhD",{"name":44,"role":23,"phone":24,"phoneExt":10,"email":45},"David Mingo-Botin, PhD","david.mingo@salud.madrid.org",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Francisco Arnalich-Montiel","Lead investigator of the Ophtalmology department","100613346","success-score-validation-in-fuchs-dystrophy-100613346",false,"NCT07265388","SUCCESS Score Validation in Fuchs Dystrophy","Validation and Extension of the SUCCESS Score for Fuchs Dystrophy After Cataract Surgery","SUCCESS","Inclusion Criteria:\n\n* Adults aged ≥40 years.\n* Clinical diagnosis of Fuchs endothelial corneal dystrophy (FECD) grade ≥2 on the modified Krachmer scale.\n* Presence of visually significant cataract requiring phacoemulsification surgery.\n* Ability to provide informed consent and comply with study procedures.\n* Availability of preoperative Scheimpflug tomography and corneal densitometry measurements.\n\nExclusion Criteria:\n\n* Epithelial or stromal edema precluding reliable corneal imaging.\n* Previous ocular surgery (including corneal or intraocular procedures).\n* Corneal trauma, infection, or inflammation affecting endothelial integrity.\n* Coexisting ocular pathologies that could confound postoperative assessment (e.g., advanced glaucoma, macular degeneration).","ALL","40 Years",{"count":61,"type":62},250,"ESTIMATED","5 Years","OBSERVATIONAL","This prospective multicenter diagnostic study aims to externally validate and extend the SUCCESS Score for predicting the need for endothelial keratoplasty after cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). The model's performance and clinical utility are assessed using discrimination, calibration, and reclassification metrics.",[67],"Fuchs Endothelial Corneal Dystrophy",[67,69,70,71,72,73],"Cataract Surgery","endothelial keratoplasty","Diagnostic Accuracy","Prognostic Validation","Predictive Modeling","2025-11-24",{"date":76,"type":77},"2025-12-04","ACTUAL",{"date":79,"type":77},"2020-06-01",{"date":81,"type":62},"2026-12",{"name":5,"class":6},1]