[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356239":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":56,"collaborators":36,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":36,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":36,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":36,"overallStatus":40,"whyStopped":36,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Pacific Clear Vision Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulsed, accelerated","EXPERIMENTAL","18 mW, 5 sec, 5 sec off, 10 minutes of illumination",[13],"Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional","ACTIVE_COMPARATOR","9 mW, continuous 10 minutes of illumination",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution","Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea",[15,9],[26],"Corneal crosslinking",[28],{"name":29,"affiliation":30,"role":31},"BALAMURALI AMBATI, MD, PhD","PCVI","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","541-343-5000",null,"bambati@pcvi.com",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Eugene","Oregon","97401","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-123.08675,44.05207,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":36,"email":37},"BALAMURALI AMBATI, MD","706-231-3958",{"type":57,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100356239","phase-1-safety-and-effectiveness-of-the-pxl-platinum-330-system-for-corneal-cross-linking-100356239",false,"NCT03918408","Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking","Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions","Inclusion Criteria:\n\nSubjects who have one or both eyes that meet criteria 1 \\& 2 and 1 or more of the following criteria will be considered candidates for this study.\n\n* 12 years of age or older\n* Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)\n* Presence of central or inferior steepening.\n* Axial topography consistent with keratoconus\n* Presence of one or more findings associated with keratoconus such as:\n* Fleischer ring\n* Vogt's striae\n* Decentered corneal apex\n* Munson's sign\n* Rizzutti's sign\n* Apical Corneal scarring consistent with Bowman's breaks\n* Scissoring of the retinoscopic reflex\n* Crab-claw appearance on topography\n* Steepest keratometry (Kmax) value ≥ 47.20 D\n* I-S keratometry difference \\> 1.5 D on the Pentacam\u002FGalilei\u002FOrbscan\u002FCassini map or topography map\n* Posterior corneal elevation \\>16 microns\n* Thinnest corneal point \\\u003C485 microns\n* AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).\n* Signed written informed consent\n* Willingness and ability to comply with schedule for follow-up visits\n* For Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:\n* Contact Lens Type Minimum Discontinuation Time:\n* Soft: 1 Week\n* Soft Extended Wear: 2 Weeks\n* Soft Toric: 3 Weeks\n* Rigid gas permeable: 2 Weeks per decade of wear\n* Scleral Lenses\n* Investigator Discretion \\[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\\]\n* Signed written informed consent\n* Willingness and ability to comply with schedule for follow-up visits\n\nExclusion Criteria (any of the following are reasons for exclusion):\n\n* Eyes classified as either normal or atypical normal on the severity grading scheme.\n* Corneal pachymetry at the screening exam that is \\\u003C330 microns at the thinnest point in the eye(s) to be treated.\n* Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:\n* History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)\n* Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.\n* Pregnancy (including plan to become pregnant) or lactation during the course of the study\n* A known sensitivity to study medications\n* Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.\n* Patients with active medical implants (e.g. cardiac pacemakers)'\n* Patients who are aphakic\u002F pseudophakic","ALL","12 Years","45 Years",{"count":69,"type":70},300,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.",[76,77,78],"Keratoconus, Unstable","Bacterial Keratitis","Ectasia of Cornea","2024-11-09",{"date":81,"type":82},"2024-11-12","ACTUAL",{"date":84,"type":82},"2019-09-01",{"date":86,"type":70},"2030-12",{"name":5,"class":6},1]