[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649088":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":15,"collaborators":10,"id":17,"slug":18,"hasResults":19,"nctId":20,"briefTitle":21,"officialTitle":22,"acronym":10,"eligibilityCriteria":23,"healthyVolunteers":24,"sex":25,"minAge":26,"maxAge":10,"enrollmentInfo":27,"targetDuration":10,"studyType":30,"phases":10,"briefSummary":31,"conditions":32,"keywords":35,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":10},{"fullName":5,"class":6},"Vienna Hospital Association","OTHER_GOV",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients with Fuchs endothelial corneal dystrophy (FECD)",null,"Patients with Fuchs endothelial corneal dystrophy (FECD). Clinical diagnosis of FECD based on slit-lamp findings, graded according to Krachmer et al. (1978).",{"label":13,"type":10,"description":14,"interventionNames":10},"Non-FECD","Patients without Fuchs endothelial corneal dystrophy (FECD). Control cohort: No clinical evidence of corneal endothelial disease at baseline (no signs consistent with FECD or other endothelial pathology)",{"type":16,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100649088","postoperative-cct-in-fecd-vs-non-fecd-100649088",false,"NCT07731945","Postoperative CCT in FECD vs. Non-FECD","Central Corneal Thickness After Cataract Surgery in Eyes With Fuchs Endothelial Corneal Dystrophy (FECD) Compared With Non-FECD Eyes: A Prospective, Controlled, Non-interventional Observational Clinical Study","Inclusion Criteria:\n\n1. Signed written informed consent for participation and for use of routine clinical data in pseudonymised form.\n2. Age ≥50 years at the time of cataract surgery.\n3. Scheduled cataract surgery (unilateral\u002Fbilateral cataract).\n4. No evidence of other ophthalmic diseases (e.g. macular pathology)\n\n   Cohort-specific inclusion:\n5. FECD cohort: Clinical diagnosis of FECD based on slit-lamp findings, graded accord-ing to Krachmer et al. (1978) as documented in routine care.\n6. Control cohort: No clinical evidence of corneal endothelial disease at baseline (no signs consistent with FECD or other endothelial pathology) as documented in routine care.\n\nExclusion Criteria:\n\n1. Corneal scars\n2. Pseudoexfoliation (PEX) syndrome\n3. Glaucoma\n4. Uveitis\n5. Diabetic retinopathy\n6. Other relevant ophthalmic disorders (e.g. retinal degeneration, macular or corneal pa-thologies)\n7. Previous intraocular surgery (including laser procedures)\n8. Ocular trauma (within the past 6 months)\n9. Pregnancy (if applicable, pregnancy must be excluded by a β-hCG test)\n10. CCT \\> 625μm",true,"ALL","50 Years",{"count":28,"type":29},98,"ESTIMATED","OBSERVATIONAL","This single-centre, prospective, controlled, non-interventional observational clinical study aims to characterize early postoperative corneal thickness behaviour after routine phacoemulsification cataract surgery in eyes with Fuchs endothelial corneal dystrophy (FECD) compared with non-FECD controls, using exclusively standard-of-care perioperative assessments. To compare central corneal thickness (CCT) six weeks postoperatively between FECD and non-FECD eyes, adjusting for baseline (preoperative) CCT.\n\nAll participants undergo routine phacoemulsification cataract surgery and routine perioperative assessments. Data are collected from the standard-of-care documentation at the following time points:\n\n1. Preoperative baseline visit (routine cataract work-up)\n2. Study specific postoperative follow-up at approximately 6 weeks. Each participant will attend a study-specific follow-up visit at 6 weeks postoperatively and contributes study-specific follow-up data up to this time point.\n\nThe routine clinical parameters assessed (as available per standard practice) include:\n\n(A) Medical history \u002F baseline characteristics and documentation of ocular\u002Fsystemic comorbidities and topical medication.\n\n(B) Best-corrected visual acuity (BCVA) (logMAR).\n\n(C) Intraocular pressure (IOP) measured by Goldmann applanation tonometry (GAT).\n\n(D) Slit-lamp examination (including assessment of corneal clarity\u002Fedema and anterior segment findings) with fundoscopy as routinely documented.\n\n(E) Central corneal thickness (CCT) measurement using routine clinical devices. All measurements will be performed at a consistent time of day for each patient.\n\n(F) Anterior segment optical coherence tomography (AS-OCT) using Casia2.\n\n(G) Anterior segment Scheimpflug tomography (Pentacam Oculus AXL).\n\n(H) Endothelial cell assessment or Endothelial Cell Count (ECC) examined with NIDEK® CEM-530 Specular Microscope:\n\n* Cell Density (CD) or Cell Count. Expressed as Cells\u002Fmm²\n* Coefficient of Variation (CV), represents the degree of variation in cell size (Polymegethism)\n* Percentage (%) of six-sided (hexagon) cells (HEX)\n* Standard Deviation (SD) of the average cell area.",[33,34],"Fuchs Endothelial Corneal Dystrophy","Cataract (Post-operative Cataract Surgery Follow-up)",[36,33,37,38,39],"Postoperative CCT","FECD","CCT in FECD","Cataract Surgery FECD","NOT_YET_RECRUITING","2026-08-05",{"date":43,"type":44},"2026-08-10","ACTUAL",{"date":46,"type":29},"2026-07-20",{"date":48,"type":29},"2027-08",{"name":5,"class":6}]