[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100387062":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":29,"responsibleParty":42,"collaborators":18,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":18,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":18,"overallStatus":31,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Singapore Eye Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TE-EK treatment group","EXPERIMENTAL","The TE-EK surgery will be performed by the Principle Investigator with a standard DSAEK technique. The PI has performed over 300, EK surgeries and we have previously shown that the corneal endothelial loss rates from the PI are 16% at 1 year with a primary graft failure rates of \\\u003C1.5%. A patient's participation in the study or not will not change the treatment strategy in any manner.",[13],"Other: TE-EK treatment group",[15],{"type":6,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"Transplantation of tissue-engineered endothelial graft through DSAEK procedure.",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Jodhbir Mehta","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Lee Yan Lim","CONTACT","+65 6576 7322","lim.lee.yan@seri.com.sg",[30],{"facility":5,"status":31,"city":32,"state":18,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Singapore","SG",{"type":35,"coordinates":36},"Point",[37,38],103.85007,1.28967,{"lat":38,"lon":37},[41],{"name":25,"role":26,"phone":18,"phoneExt":18,"email":18},{"type":22,"investigatorFullName":21,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Senior Consultant Head Corneal and External Eye Disease and Refractive Service","100387062","phase-1-safety-and-efficacy-of-tissue-engineered-endothelial-keratoplasty-100387062",false,"NCT04319848","Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty","Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)","TE-EK","Inclusion Criteria:\n\nPatients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from a variety of conditions including:\n\n* Fuchs' endothelial dystrophy\n* Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy\n\nExclusion Criteria:\n\n* Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for TE-EK surgery as opposed to penetrating keratoplasty\n* Patients with complex anterior segment complications precluding a successful TE-EK procedure\n* Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation\n* Post-laser iridotomy or glaucoma related corneal decompensation\n* Patients not keen to participate in the clinical trial\n* Patients who are below 21 years of age or above 80 years of age\n* Patients who are pregnant\n* Patients who are cognitively impaired\n* Patients who are prisoners\n* Patients who are allergic to antibiotics","ALL","21 Years","80 Years",{"count":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","Assessment of safety and efficacy of tissue-engineered corneal endothelial graft material generated using cultured human corneal endothelial cells for tissue-engineered endothelial keratoplasty (TE-EK).",[63,64,65,66],"Mild to Moderate Corneal Endothelial Decompensation","Bullous Keratopathy","Fuchs' Endothelial Dystrophy","Post-surgical Corneal Decompensation (Irreversible)","2025-09-05",{"date":69,"type":70},"2025-09-12","ACTUAL",{"date":72,"type":70},"2017-12-01",{"date":74,"type":57},"2028-06",{"name":5,"class":6},1]