[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589625":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Hotel Dieu de France Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Insulin drops","ACTIVE_COMPARATOR","Eyes receiving eye drops containing human insulin 1U\u002FmL",[13],"Drug: insulin eye drops",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Eyes only receiving artificial tears",[19],"Drug: Artificial tears eye-drops",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","insulin eye drops","Use of topical insulin eye drops following a standard excimer laser photo-refractive keratecotmy in myopic\u002Fastigmatic patients, in order to examine its efficacy in promoting corneal epithelial healing and patient comfort",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Artificial tears eye-drops","The other arm receiving only artificial tears",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Elie Raad, MD","CONTACT","96171092022","eliejraad@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hotel Dieu de France hospital","Beirut","166830","Lebanon","LB",{"type":45,"coordinates":46},"Point",[47,48],35.50157,33.89332,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":53,"phoneExt":26,"email":54},"Alexandre Schakal, MD","9613258583","alecschakal@hotmal.com",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100589625","phase-4-efficacy-of-topical-insuline-in-corneal-epithelial-healing-post-prk-100589625",false,"NCT06956846","Efficacy of Topical Insuline in Corneal Epithelial Healing Post PRK","Efficacy of Topical Insuline Drops in Corneal Epithelial Healing Post PRK in Non Diabetic Patients: an Randomized-controlled Trial","Inclusion Criteria:\n\n* Myopic or astigmatic patient undergoing excimer laser PRK\n\nExclusion Criteria:\n\n* diabetes mellitus prior ocular surgery ocular surface disease (including dry eye disease, history of herpetic keratitis) previous ocular trauma use of systemic corticosteroids",true,"ALL","18 Years",{"count":68,"type":69},100,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","A prospective randomized double-blind controlled trial will be conducted. The informed consent of each patient will be obtained prior to the procedure.\n\nAll patients will undergo a classic PRK procedure\n\nPatients will be instructed to use eye drops blindly in both eyes at a frequency of six times daily:\n\n* In one eye: Insulin drops formulated by combining regular human insulin with artificial tears containing polyethylene glycol (PEG 400) 0,25% at a concentration of 1 unit per milliliter.\n* In the other eye: Placebo drops containing only artificial tears. For the double-blind trial, two identical vials will be provided to each patient: one labeled R (for the right eye) and one labeled L (for the left eye). Using the bloc randomization method, the pharmacy will be the only entity aware of the composition of each vial, ensuring that 50% of patients use insulin drops in the right eye and 50% in the left eye.\n\nEvery week the drops will be prepared one day prior to the PRK procedure and will be stored in a refrigerator, to be used within one week of their preparation date.\n\nPatients will be examined by two ophthalmology residents on days 2 and 4 post-operatively.\n\nThe size of the epithelial defect in both eyes will be measured using the ImageJ software. Thus, the primary outcome of the study is the ulceration closure rate: the smaller the defect, the faster the epithelial healing is.\n\nAdditionally, a comparison of subjective symptoms reported by the patient in each eye will be recorded.",[75],"Corneal Epithelial Wound Healing","NOT_YET_RECRUITING","2025-04-25",{"date":79,"type":80},"2025-05-04","ACTUAL",{"date":77,"type":69},{"date":83,"type":69},"2025-07",{"name":5,"class":6},1]