[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519809":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":57,"collaborators":31,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":31,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":31,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":44,"whyStopped":31,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Singapore Eye Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Participants in this group will be asked to instill Glanatec Ophthalmic Solution (containing Ripasadil 0.4%) 4 times a day for 1 month following cataract removal surgery.",[13],"Drug: Ripasudil",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery.",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ripasudil","Glanatec Ophthalmic Solution 0.4% W\u002FV with ripasudil hydrochloride hydrate as active ingredient is currently being used by patients with ocular hypertension or open-angle glaucoma.\n\nInhibition of Rho kinase to facilitate aqueous outflow from the conventional outflow pathway via the trabecular meshwork and Schlemm's canal has been suggested as the IOP-lowering mechanism of action by ripasudil.",[9],[27],"Glanatec",{"type":6,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Saline eye drops",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Marcus Ang","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","+65 62277255","Marcus.Ang@Singhealth.com.sg",[42],{"facility":43,"status":44,"city":45,"state":45,"zip":46,"country":45,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Singapore National Eye Centre","RECRUITING","Singapore","168751","SG",{"type":49,"coordinates":50},"Point",[51,52],103.85007,1.28967,{"lat":52,"lon":51},[55,56],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},{"name":34,"role":35,"phone":31,"phoneExt":31,"email":31},{"type":35,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Marcus Ang Han Nian","A\u002FProfessor","100519809","phase-3-the-effects-of-ripasudil-in-patients-with-fed-undergoing-femtosecond-laser-assisted-cataract-surgery-100519809",false,"NCT06048380","The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery","The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery","Inclusion Criteria:\n\n1. Patients with FED who will be listed for cataract surgery as part of standard clinical practice (A cataract will be defined as clouding of the lens that interferes with normal vision).\n2. Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.\n3. Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.\n4. Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery.\n\nExclusion Criteria:\n\n1. Patients who are unable to give consent.\n2. An only-functioning eye in a patient who has lost visual potential in the contralateral eye.\n3. Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study.\n4. History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease.\n5. Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%","ALL","50 Years","100 Years",{"count":71,"type":72},120,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery. The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study.",[78,79],"Fuchs' Endothelial Dystrophy","Cataract",[23],"2025-01-27",{"date":83,"type":84},"2025-01-29","ACTUAL",{"date":86,"type":72},"2025-03-01",{"date":88,"type":72},"2025-07",{"name":5,"class":6},1]