[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507256":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":27,"studyPopulation":20,"armGroups":28,"interventions":35,"overallOfficials":43,"centralContacts":48,"locations":56,"responsibleParty":122,"collaborators":20,"id":124,"slug":20,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":20,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":20,"enrollmentInfo":132,"targetDuration":20,"studyType":135,"phases":136,"briefSummary":137,"conditions":138,"keywords":20,"overallStatus":72,"whyStopped":20,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Myra Vision Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Intraocular Pressure","Percent change in IOP from baseline to the 12-month visit","12 Months",{"measure":14,"description":15,"timeFrame":12},"Adverse Events","Number and percentage of subjects having any adverse event",[17],{"measure":18,"description":19,"timeFrame":12},"Glaucoma Medication Usage","Change in number of medications used compared to baseline",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"NA","SINGLE_GROUP","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE","This is a prospective, nonrandomized, open-label feasibility clinical trial, to evaluate the surgical procedure, safety and effectiveness of the Calibreye System in reducing intraocular pressure in subjects with open angle glaucoma.",[29],{"label":30,"type":31,"description":32,"interventionNames":33},"Investigational Device Arm","EXPERIMENTAL","Subjects will receive a Calibreye glaucoma device (permanent implant)",[34],"Device: Calibreye System",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","Calibreye System","Implantation of a glaucoma device to reduce intraocular pressure",[30],[42],"Glaucoma device, Glaucoma implant, Aqueous Shunt",[44],{"name":45,"affiliation":46,"role":47},"Keith Barton, MD","Moorfields Eye Hospital NHS Foundation Trust","STUDY_CHAIR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":20,"email":53},"Shienal Patel","CONTACT","14085602500","info@myravision.com",{"name":55,"role":51,"phone":52,"phoneExt":20,"email":53},"Michelle Tran",[57,70,89,105],{"facility":58,"status":59,"city":60,"state":20,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":20},"Dr. Agarwal's Eye Hospital Ltd.","ACTIVE_NOT_RECRUITING","Chennai","600018","India","IN",{"type":65,"coordinates":66},"Point",[67,68],80.27847,13.08784,{"lat":68,"lon":67},{"facility":71,"status":72,"city":73,"state":20,"zip":20,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Centro Oftalmologico de Chihuahua","RECRUITING","Chihuahua City","Mexico","MX",{"type":65,"coordinates":77},[78,79],-106.08889,28.63528,{"lat":79,"lon":78},[82,86],{"name":83,"role":51,"phone":84,"phoneExt":20,"email":85},"Mayra Salinas","52 61 4364 7898","mayra_dj@hotmail.com",{"name":87,"role":88,"phone":20,"phoneExt":20,"email":20},"Ana Cristina Luna, MD","PRINCIPAL_INVESTIGATOR",{"facility":90,"status":72,"city":91,"state":20,"zip":92,"country":74,"countryCode":75,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Oftalmología Láser de Puebla S.C.","Puebla City","72540",{"type":65,"coordinates":94},[95,96],-98.20723,19.04778,{"lat":96,"lon":95},[99,103],{"name":100,"role":51,"phone":101,"phoneExt":20,"email":102},"Aimee Hernandez","(22) 2257-0970","aimeehdz20@gmail.com",{"name":104,"role":88,"phone":20,"phoneExt":20,"email":20},"Gabriel Salomón Lazcano Gómez, MD",{"facility":106,"status":72,"city":107,"state":20,"zip":20,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Panama Eye Center","Panama City","Panama","PA",{"type":65,"coordinates":111},[112,113],-79.51973,8.9936,{"lat":113,"lon":112},[116,120],{"name":117,"role":51,"phone":118,"phoneExt":20,"email":119},"Idabel Orillac","+507 269 7475","idabelo28@gmail.com",{"name":121,"role":88,"phone":20,"phoneExt":20,"email":20},"Lautaro Vera, MD",{"type":123,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100507256",false,"NCT05885022","Feasibility Clinical Evaluation of the Calibreye System","Inclusion Criteria:\n\n* Open angle, pseudoexfoliative or pigmentary glaucoma\n* IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg\n* Visual field mean deviation score of -3dB or worse\n* Area of healthy, free and mobile conjunctiva in the target quadrant\n* Shaffer angle grade ≥ 3 in the target quadrant\n\nExclusion Criteria:\n\n* Angle closure glaucoma\n* Congenital, neovascular or other secondary glaucomas\n* Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring \\> 3 months prior to the preoperative visit)\n* Previous glaucoma shunt\u002Fvalve in the target quadrant\n* Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit\n* History of corneal surgery, corneal opacities or corneal disease\n* Active diabetic retinopathy",true,"ALL","18 Years",{"count":133,"type":134},60,"ESTIMATED","INTERVENTIONAL",[22],"To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.",[139],"Glaucoma, Open-Angle","2025-12-08",{"date":142,"type":143},"2025-12-15","ACTUAL",{"date":145,"type":143},"2023-05-31",{"date":147,"type":134},"2028-12",{"name":5,"class":6},4]