[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376905":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":34,"locations":40,"responsibleParty":86,"collaborators":88,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":19,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":19,"enrollmentInfo":101,"targetDuration":19,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":19,"overallStatus":42,"whyStopped":19,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"CooperVision International Limited (CVIL)","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Paragon CRT®100 Contact Lens","EXPERIMENTAL","participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months.",[13],"Device: Paragon CRT®100 Contact Lens",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.",[9],null,[21,25,28,31],{"name":22,"affiliation":23,"role":24},"Jiang Jun, MD","The Affiliated Eye Hospital of Wenzhou Medical University","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Qu Xiao Mei, MD","Eye & ENT Hospital of Fudan University",{"name":29,"affiliation":30,"role":24},"Yang Zhi Kuan, MD","Changsha Aier Eye Hospital",{"name":32,"affiliation":33,"role":24},"Li Li Hua, MD","Tianjin Eye Hospital",[35],{"name":36,"role":37,"phone":38,"phoneExt":19,"email":39},"Jose Vega, OD, MSc","CONTACT","9256402964","jvega2@coopervision.com",[41,56,64,75],{"facility":30,"status":42,"city":43,"state":19,"zip":19,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Shanghai","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},[53],{"name":54,"role":37,"phone":55,"phoneExt":19,"email":19},"Yang Zhikuan, MD","133 8007 1988",{"facility":27,"status":42,"city":43,"state":19,"zip":19,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},{"type":47,"coordinates":58},[49,50],{"lat":50,"lon":49},[61],{"name":62,"role":37,"phone":63,"phoneExt":19,"email":19},"Qu Xiaomei, MD","137 6066 4837",{"facility":33,"status":42,"city":65,"state":19,"zip":19,"country":44,"countryCode":45,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Tianjin",{"type":47,"coordinates":67},[68,69],117.17667,39.14222,{"lat":69,"lon":68},[72],{"name":73,"role":37,"phone":74,"phoneExt":19,"email":19},"Li Li Hua","136 5180 3988",{"facility":23,"status":42,"city":76,"state":19,"zip":19,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Wenzhou",{"type":47,"coordinates":78},[79,80],120.66682,27.99942,{"lat":80,"lon":79},[83],{"name":84,"role":37,"phone":85,"phoneExt":19,"email":19},"Jiang Jun","135 0651 1080",{"type":87,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[89],{"name":90,"class":6},"TigerMed","100376905","post-market-follow-up-study-on-paragon-crt-100-paflufocon-d-100376905",false,"NCT04187599","Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)","Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy for Temporary Myopic Refractive Power Reduction","Inclusion Criteria:\n\n1. Patient contact lens refraction should fit within the available parameters of the study lenses (spherical power within -4.00D and the cylinder power within 1.50D).\n2. Is willing to comply with the wear and visit schedule.\n3. Is willing to participate and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Age under 8 years old\n2. Any ocular abnormalities, undergone corneal surgery, or history of ocular trauma, active corneal infections (corneal inflammation), corneal curvature less than 40.00D or more than 46.00D\n3. Best corrected visual acuity less than 1.0D\n4. Pregnant, lactating or near-pregnancy\n5. The eye has the following conditions:\n\n   1. Acute and subacute inflammations or infection of the anterior segment of the eye\n   2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids, e.g. dacryocystitis, conjunctivitis, blepharitis and other inflammation, glaucoma, etc.\n   3. Severe insufficiency of tears (TBUT≤5s).\n   4. Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care\n   5. Any active corneal infection (bacterial, fungal or viral).\n6. Manifested strabismus\n7. Abnormal intra-ocular pressure\n8. Suffering from systemic diseases, resulting in low immunity, or affecting corneal re-shaping (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, mental patients, etc.)\n9. Under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature.\n10. Examination result indicate any contraindication or not suitable for OrthoK lens wear\n11. Participated in pharmaceutical clinical study 3 months before the date of the screening or participated any other medical devices research study within 30 days of the screening\n12. Only eye fulfills inclusion criteria\n13. History of any ocular operations\n14. Unable to follow investigator's instruction\n15. Any other condition not suitable for the study per investigator's judgement",true,"ALL","8 Years",{"count":102,"type":103},250,"ESTIMATED","INTERVENTIONAL",[106],"NA","The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.",[109],"Myopia","2019-12-04",{"date":112,"type":113},"2019-12-05","ACTUAL",{"date":115,"type":113},"2019-08-29",{"date":117,"type":103},"2020-12-31",{"name":5,"class":6},4]