[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"keratoconus-unstable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:keratoconus-unstable":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":42},"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",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100418670","early-phase-1-treating-corneal-thinning-conditions-with-ccl-vario-riboflavin-cxl-100418670","NCT04731727","Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)","Safety and Effectiveness of the CCL Vario System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions","CXL","Inclusion Criteria:\n\n* Presence of central or inferior corneal steepening\n* Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration\n* Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:\n* Fleischer ring\n* Vogt's striae\n* Decentered corneal apex\n* Munson's sign\n* Rizutti'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 \\> or = 47.20 D\n* I-S keratometry difference \\> 1.5 D on the Orbscan map\n* Posterior corneal elevation \\> 16 microns\n* Thinnest corneal point \\\u003C 485 microns\n* Post LASIK\u002FPRK stromal ablation depth \\\u003C 300 microns or expected keratometry \\> 47.2 D, or post-PRK\u002FSMILE in keratoconus suspect eyes\n* Bacterial or fungal corneal keratitis persistent and not responding despite \\> 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of \\> 25% corneal thickness\n* Contact Lens Wearers Only:\n* Removal of contact lenses for the required period of time prior to the screening refraction:\n\nContact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid Gas Permeable 2 Weeks per decade of wear\n\n* Signed written informed consent\n* Willingness and ability to comply with schedule for follow-up visits\n\nExclusion Criteria:\n\n* Eyes classified as either normal or atypical normal on the severity grading scheme\n* Corneal pachymetry at the screening exam that is \\\u003C 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or \\\u003C 300 microns when the hypotonic riboflavin will be used.\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\n  1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)\n  2. 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing",{"count":52,"type":21},600,[54],"EARLY_PHASE1","Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.",[27],"NOT_YET_RECRUITING","2021-05-21",{"date":60,"type":34},"2021-05-25",{"date":62,"type":21},"2021-06-30",{"date":64,"type":21},"2026-12",{"name":66,"class":41},"Kent Wellish MD"]