[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586944":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":50,"collaborators":52,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":33,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Corneal Rigid Gas Permeable Contact Lens","ACTIVE_COMPARATOR","Small diameter RGP lens (TD \\\u003C HVID).",[13],"Device: Rose K2",{"label":15,"type":10,"description":16,"interventionNames":17},"Scleral Rigid Gas Permeable Contact Lens","Large diameter RGP lens (TD\\>HVID).",[18],"Device: Onefit MED",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Rose K2","Corneal RGP lens with flexible parameters.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Onefit MED","Scleral RGP lens with flexible parameters.",[15],[31],{"facility":32,"status":33,"city":34,"state":25,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Aarhus University Hospital","RECRUITING","Aarhus","8200","Denmark","DK",{"type":39,"coordinates":40},"Point",[41,42],10.21076,56.15674,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Benjamin Sukusu Nielsen, Cand.san opto","CONTACT","+45 29460340","bensen@clin.au.dk",{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[53],{"name":32,"class":6},"100586944","effect-of-corneal-and-scleral-rgp-lenses-on-ocular-health-and-visual-quality-in-keratoconus-100586944",false,"NCT06921967","Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus","A Comparison of Ocular Health and Visual Quality With Corneal and Scleral Rigid Gas Permeable Lenses in Keratoconus Patients","Inclusion Criteria:\n\n* Keratoconus, best spectacle corrected visual acuity \\>0.00 log of minimum angle of resolution (logMAR) and age between 18 to 40\n\nExclusion Criteria:\n\n* K-max \\>60D, RGP lens wear at baseline and ocular surface disease, verified through examination of the ocular surface and patient history","ALL","18 Years","40 Years",{"count":65,"type":66},50,"ESTIMATED","INTERVENTIONAL",[69],"NA","This study aims to compare the ocular health and visual quality of corneal rigid gas permeable lenses (CRGPL) and scleral rigid gas permeable lenses (SRGPL) for patients with keratoconus in a crossover clinical trial. The study will analyze subjective and objective outcomes, including best corrected visual acuity, contrast sensitivity, higher-order aberrations and subjective perception of visual function and comfort. It will also investigate the impact of both lens types on the health of the ocular surface, including evaluation of corneal, conjunctival, and scleral tissues, and tear film. Only one randomized controlled trial has compared the effect of CRGPL and SRGPL wear for patients with an ectatic corneal disorder. With the increasing popularity of SRGPL, examining the differences in efficacy, safety, and patient-reported outcomes between the two types of lenses is increasingly relevant.",[72,73],"Keratoconus","Irregular Astigmatism",[75,76,77,78,79,80,81,82,83,84,85,86,72],"Contact Lenses","Scleral Lenses","Corneal Lenses","Rigid gas permeable lenses","Rigid lenses","GP lenses","RGP lenses","Visual Acuity","Contrast Sensitivity","Higher Order Aberrations","Dry Eye Disease","Irregular Astimatism","2025-08-18",{"date":89,"type":90},"2025-08-24","ACTUAL",{"date":92,"type":90},"2025-08-15",{"date":94,"type":66},"2028-02-29",{"name":5,"class":6},1]