[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482395":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":41,"armGroups":42,"interventions":53,"overallOfficials":63,"centralContacts":68,"locations":74,"responsibleParty":91,"collaborators":37,"id":93,"slug":37,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":37,"enrollmentInfo":101,"targetDuration":37,"studyType":104,"phases":37,"briefSummary":105,"conditions":106,"keywords":37,"overallStatus":77,"whyStopped":37,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Cutting Edge SAS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"DCIVA at 66 cm","The primary objective of this study is 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","1 month",[14,17,19,22,24,27,30,34],{"measure":15,"description":16,"timeFrame":12},"Monocular UDVA","distance",{"measure":18,"description":16,"timeFrame":12},"Monocular BCDVA",{"measure":20,"description":21,"timeFrame":12},"Monocular UIVA","66 cm",{"measure":23,"description":21,"timeFrame":12},"Monocular DCIVA",{"measure":25,"description":26,"timeFrame":12},"Refraction","subjective",{"measure":28,"description":29,"timeFrame":12},"Potential complications","postoperative",{"measure":31,"description":32,"timeFrame":33},"Rotational stability","in degrees","Peroperatively, day 0, Month 1",{"measure":35,"description":36,"timeFrame":12},"Subjective quality of vision","PROM",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"CASE_CONTROL","PROSPECTIVE","Patient requiring bilateral cataract surgery",[43,48],{"label":44,"type":37,"description":45,"interventionNames":46},"Test device (Synthesis Plus Toric)","Requiring bilateral cataract surgery with pre-existing astigmatism",[47],"Device: Implantation of Synthesis Plus Toric IOL (investigational device)",{"label":49,"type":37,"description":50,"interventionNames":51},"Control device (Synthesis Plus)","Requiring bilateral cataract surgery",[52],"Device: Implantation of Synthesis Plus IOL (control device)",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":37},"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.",[49],{"type":55,"name":60,"description":61,"armGroupLabels":62,"otherNames":37},"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.",[44],[64],{"name":65,"affiliation":66,"role":67},"Boris Dethinne, MD","Visis","PRINCIPAL_INVESTIGATOR",[69],{"name":70,"role":71,"phone":72,"phoneExt":37,"email":73},"Line Bettinelli, OD","CONTACT","0619530701","line.bettinelli@cutting-edge.fr",[75],{"facility":76,"status":77,"city":78,"state":37,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"VISIS","RECRUITING","Perpignan","66000","France","FR",{"type":83,"coordinates":84},"Point",[85,86],2.89541,42.69764,{"lat":86,"lon":85},[89],{"name":90,"role":71,"phone":37,"phoneExt":37,"email":37},"Boris DETHINNE, MD",{"type":92,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","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":102,"type":103},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.",[107,108,109],"Cataract","Surgery","IOL","2025-02-10",{"date":112,"type":113},"2025-02-11","ACTUAL",{"date":115,"type":113},"2022-10-10",{"date":117,"type":103},"2025-10",{"name":5,"class":6},1]