[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589625":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":29,"interventions":42,"overallOfficials":18,"centralContacts":52,"locations":58,"responsibleParty":76,"collaborators":18,"id":78,"slug":18,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":18,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":18,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":18,"overallStatus":96,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Hotel Dieu de France Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Corneal epithelial healing","Corneal epithelial defect will be measured ar Day 2 and Day 4 using slit images.","From enrollement to day 4 post PRK",[14],{"measure":15,"description":16,"timeFrame":17},"Pain\u002Fdiscomfort","Subjective patient paint\u002Fdiscomfort scores will be recorded and compared ar day 2 and day 4","day 4 post PRK",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"TRIPLE",[26,27,28],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Insulin drops","ACTIVE_COMPARATOR","Eyes receiving eye drops containing human insulin 1U\u002FmL",[35],"Drug: insulin eye drops",{"label":37,"type":38,"description":39,"interventionNames":40},"Placebo","PLACEBO_COMPARATOR","Eyes only receiving artificial tears",[41],"Drug: Artificial tears eye-drops",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"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",[31],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":18},"Artificial tears eye-drops","The other arm receiving only artificial tears",[37],[53],{"name":54,"role":55,"phone":56,"phoneExt":18,"email":57},"Elie Raad, MD","CONTACT","96171092022","eliejraad@gmail.com",[59],{"facility":60,"status":18,"city":61,"state":18,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Hotel Dieu de France hospital","Beirut","166830","Lebanon","LB",{"type":66,"coordinates":67},"Point",[68,69],35.50157,33.89332,{"lat":69,"lon":68},[72],{"name":73,"role":55,"phone":74,"phoneExt":18,"email":75},"Alexandre Schakal, MD","9613258583","alecschakal@hotmal.com",{"type":77,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"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.",[95],"Corneal Epithelial Wound Healing","NOT_YET_RECRUITING","2025-04-25",{"date":99,"type":100},"2025-05-04","ACTUAL",{"date":97,"type":89},{"date":103,"type":89},"2025-07",{"name":5,"class":6},1]