[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626898":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":50,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":82,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL",null,[13],"Device: combined cataract and lamellar endothelial keratoplasty",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","combined cataract and lamellar endothelial keratoplasty","PureSee™ IOL in combined cataract and lamellar endothelial keratoplasty",[9],[21],{"name":22,"affiliation":5,"role":23},"Karolien Termote, MF, Febo","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Karolien Termote, MD, Febo","CONTACT","+32475878777","karolien.termote@uzbrussel.be",[31],{"facility":32,"status":11,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"University Hospital Leuven","Leuven","3000","Belgium","BE",{"type":38,"coordinates":39},"Point",[40,41],4.70093,50.87959,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":46,"phoneExt":11,"email":47},"Heleen Delbeke, MD, PhD","+3216332370","heleen.delbeke@uzleuven.be",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[51],{"name":52,"class":6},"Universitaire Ziekenhuizen KU Leuven","100626898","partial-range-of-field-iols-in-dmek-enabled-procedures-100626898",false,"NCT07441616","Partial Range Of Field IOLs in DMEK-Enabled Procedures","A Feasibility Study Evaluating Visual Outcomes of Extended Partial Range of Field Refractive Intraocular Lenses in Patients Undergoing Combined Cataract Surgery and Descemet Membrane Endothelial Keratoplasty (Triple DMEK)","PROFIDE","Inclusion Criteria:\n\n* Patients with bilateral cataract grade greater than II, according to the Lens Opacities Classification System III (LOCS III) , combined with FECD displaying clinical or subclinical corneal edema or displaying visual disturbing guttae with at least Krachmer grade 3\n* Patients aged between 40 and 90 years\n* Capacity to read and to understand the study information and to provide informed consent, as well as Patient Reported Spectacle Independence Questionnaire (PRSIQ) and Patient Reported Visual Symptom Questionnaire (PRVSQ)\n* Patients willing and capable to attend the 6-month follow-up appointment\n\nExclusion Criteria:\n\n* history of ocular surgery\n* corneal scars\n* macular disease revealed by pre-surgical macular Optical Coherence Tomography (OCT),\n* opticopathy\n* glaucoma with reduced sensitivity of visual field\n* uveitis\n* amblyopia\n* axial length \\\u003C22mm or \\>25mm,\n* scotopic pupil size \\>5mm,\n* central corneal thickness \\>700microns,\n* corneal astigmatism \\>1 diopters (D) on biometry\n* irregular astigmatism (RMS HOA 3mm pupil \\>0.3)\n* angle kappa \\>0.3mm ((chord µ measured with Pentacam HR; Oculus, Wetzlar, Germany)","ALL","40 Years","90 Years",{"count":65,"type":66},10,"ESTIMATED","INTERVENTIONAL",[69],"NA","Study Overview\n\nThis study aims to evaluate the visual outcomes, quality of vision, and patient satisfaction after receiving an extended range PRoF intraocular lens (IOL) during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This surgery is typically performed to treat patients with both corneal endothelial dysfunction and cataracts. By testing a newer IOL, the PureSee™ extended PRoF IOL, this study hopes to improve the way ophthalmologists plan surgeries and select IOLs for these patients, ultimately helping surgeons optimize the results and expand the options available for people undergoing this procedure.\n\nPurpose of the Study\n\nThe goal of this study is to evaluate how well the PureSee™ IOL works in terms of intermediate visual acuity (how well participants can see things at an arm's length). The investigators will also measure the quality of vision, satisfaction, and whether participants need glasses after surgery.\n\nThe investigators have set the following goals for this study:\n\nPrimary Goal:\n\nTo measure how well patients can see intermediate distances (uncorrected intermediate visual acuity, or UIVA) after receiving the PureSee™ IOL during triple DMEK surgery.\n\nSecondary Goals:\n\nTo understand how independent patients are from glasses after surgery.\n\nTo measure patients' uncorrected and best-corrected visual acuity (sharpness of vision) at distance, intermediate, and near vision after surgery.\n\nTo evaluate the uncorrected defocus curve (how the vision of participants changes when focusing at different distances).\n\nTo measure contrast sensitivity (how well participants can see in low-light conditions or with subtle contrasts).\n\nWho Can Join This Study?\n\nTo participate in this study, participants need to:\n\nBe undergoing triple DMEK surgery for endothelial dysfunction and cataract at the time of enrollment.\n\nBe eligible to receive an extended range of vision IOL as part of the procedure.\n\nThis study is looking for patients who are interested in understanding how new IOL technology might improve their postoperative vision quality and reduce their dependence on glasses.\n\nWhat Will Happen During the Study?\n\nParticipants will have their visual outcomes and satisfaction measured at specific times following surgery. This includes:\n\nTesting uncorrected and best-corrected visual acuity at several distances (distance, intermediate, and near).\n\nCompleting a survey about how satisfied they are with their vision and how often they need glasses or contact lenses.\n\nUndergoing testing to measure contrast sensitivity (how well participants can see in low-light conditions).\n\nWhy Is This Study Important?\n\nThe results of this study will help doctors make better decisions about which IOLs to use during triple DMEK surgery. By evaluating the PureSee™ extended PRoF IOL, the investigators hope to expand options for patients and potentially improve visual outcomes and postoperative satisfaction. Ultimately, this study could help improve the quality of life for patients who have both cataracts and endothelial dysfunction.\n\nStudy Duration\n\nParticipants can expect to undergo their last assessment 6 months post-surgery to track their progress.",[72,73],"Cataract","Fuchs Endothelial Corneal Dystrophy",[75,76,77,78,79,80,81],"dmek","triple","endothelial keratoplasty","fuchs","cataract","edof iol","partial range of field iol","NOT_YET_RECRUITING","2026-02-23",{"date":85,"type":86},"2026-03-02","ACTUAL",{"date":88,"type":66},"2026-03",{"date":90,"type":66},"2028-02",{"name":5,"class":6},1]