[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pacific Clear Vision Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.",[27,28,29],"Keratoconus, Unstable","Bacterial Keratitis","Ectasia of Cornea","RECRUITING","2024-11-09",{"date":33,"type":34},"2024-11-12","ACTUAL",{"date":36,"type":34},"2019-09-01",{"date":38,"type":21},"2030-12",{"name":40,"class":41},"Pacific Clear Vision Institute","OTHER",""]