[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482395":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Cutting Edge SAS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test device (Synthesis Plus Toric)",null,"Requiring bilateral cataract surgery with pre-existing astigmatism",[13],"Device: Implantation of Synthesis Plus Toric IOL (investigational device)",{"label":15,"type":10,"description":16,"interventionNames":17},"Control device (Synthesis Plus)","Requiring bilateral cataract surgery",[18],"Device: Implantation of Synthesis Plus IOL (control device)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Implantation of Synthesis Plus IOL (control device)","Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Implantation of Synthesis Plus Toric IOL (investigational device)","Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.",[9],[30],{"name":31,"affiliation":32,"role":33},"Boris Dethinne, MD","Visis","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Line Bettinelli, OD","CONTACT","0619530701","line.bettinelli@cutting-edge.fr",[41],{"facility":42,"status":43,"city":44,"state":10,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"VISIS","RECRUITING","Perpignan","66000","France","FR",{"type":49,"coordinates":50},"Point",[51,52],2.89541,42.69764,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":10,"phoneExt":10,"email":10},"Boris DETHINNE, MD",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100482395","comparison-of-visual-outcomes-after-implantation-of-the-synthesis-plus-and-synthesis-plus-toric-100482395",false,"NCT05561478","Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric","DETPLUST","Inclusion Criteria:\n\n* Patient older than 50 years old\n* Patient requiring bilateral cataract surgery\n* Regular corneal astigmatism \\>0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.\n* Expected postoperative astigmatism ≤ 0.75D diopter\n* Corneal astigmatism ≤4D\n* IOL spherical equivalent power requested between 15D and 25D\n* Signed informed consent\n* Availability, willingness and sufficient cognitive awareness to comply with examination procedures\n\nNon inclusion Criteria:\n\n* Patients with a potential postoperative visual acuity of less than 5\u002F10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea.\n* Amblyopia with a visual acuity potential of less than 5\u002F10\n* IOL power needed outside the spherical equivalent diopter range: 15 to 25D\n* Difficulty for cooperation (distance from their home, general health condition)\n* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)\n* Irregular astigmatism\n* Subject with postoperative astigmatism, expected \\> 0.75 D.\n* Any ocular comorbidity\n* History of ocular trauma or prior ocular surgery including refractive procedures\n* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)\n* Patients with chronic uveitis\n* Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic\u002Fscotopic conditions, diameter (pupil\\>4mm or \\\u003C2.5 mm in photopic conditions))\n* Narrow anterior chambers (ACD ≤ 2.5 mm)\n* Any corneal pathology potentially affecting the topography (eg. Keratoconus),\n* Monophthalma patients\n* Phacodonesis\n\nExclusion criteria:\n\n* Complicated surgery\n* Inability to place the intraocular lens safely at the location planned\n* Subjects with zonular laxity\n* Postoperative endophthalmitis","ALL","50 Years",{"count":69,"type":70},72,"ESTIMATED","OBSERVATIONAL","Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.",[74,75,76],"Cataract","Surgery","IOL","2025-02-10",{"date":79,"type":80},"2025-02-11","ACTUAL",{"date":82,"type":80},"2022-10-10",{"date":84,"type":70},"2025-10",{"name":5,"class":6},1]