[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650257":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":107,"collaborators":110,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":26,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":26,"enrollmentInfo":124,"targetDuration":26,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":137,"whyStopped":26,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: RB-PDT","ACTIVE_COMPARATOR","Group 1 participants will receive natamycin 5%\u002FAmphotericin B 0.15% plus RB-PDT",[13],"Drug: Rose Bengal Photodynamic Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2: Sham RB-PDT","SHAM_COMPARATOR","Group 2 participants will receive natamycin 5%\u002FAmphotericin B 0.15% plus sham RB-PDT",[19],"Drug: Sham RB-PDT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Rose Bengal Photodynamic Therapy","RB-PDT\u002Fsham RB-PDT will occur within 5 days of initial smear\u002Fculture. For Group 1, Rose Bengal (0.1% RB in 0.9% sodium chloride) will be applied in 3-minute intervals to the de-epithelialized cornea for 30 minutes followed by irradiation with a 6mW\u002Fcm2 custom-made green LED source for 15 minutes (5.4J\u002Fcm2).\n\nA second RB-PDT procedure and repeat smear\u002Fculture will occur one week after the first procedure, following the same protocol.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham RB-PDT","Participants in Group 2 will undergo a sham procedure using topical balanced salt solution and pen light covered with a green filter. Study participants will undergo repeat scraping and culture of the corneal ulcer 30 minutes after the assigned RB-PDT procedure.\n\nA second sham RB-PDT procedure and repeat smear\u002Fculture will occur one week after the first procedure, following the same protocol.",[15],[32,56,72,89],{"facility":5,"status":26,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Palo Alto","California","94303","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-122.14302,37.44188,{"lat":42,"lon":41},[45,50,54],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Jennifer Rose-Nussbaumer, MD","CONTACT","650-498-8790","rosej@stanford.edu",{"name":51,"role":47,"phone":52,"phoneExt":26,"email":53},"Nicole Varnado, MPH","650-725-1688","nvarnado@stanford.edu",{"name":46,"role":55,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":57,"status":26,"city":58,"state":59,"zip":60,"country":36,"countryCode":37,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"University of Miami - Bascom Palmer Eye Institute","Miami","Florida","33136",{"type":39,"coordinates":62},[63,64],-80.19366,25.77427,{"lat":64,"lon":63},[67,71],{"name":68,"role":47,"phone":69,"phoneExt":26,"email":70},"Guillermo Amescua, MD","412-592-5665","GAmescua@med.miami.edu",{"name":68,"role":55,"phone":26,"phoneExt":26,"email":26},{"facility":73,"status":26,"city":74,"state":26,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Federal University of São Paulo","São Paulo","04023-062","Brazil","BR",{"type":39,"coordinates":79},[80,81],-46.63611,-23.5475,{"lat":81,"lon":80},[84,88],{"name":85,"role":47,"phone":86,"phoneExt":26,"email":87},"Ana Luisa Höfling-Lima, MD PhD","+55 11 99982-1276","analhofling@gmail.com",{"name":85,"role":55,"phone":26,"phoneExt":26,"email":26},{"facility":90,"status":26,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Aravind Eye Care System","Madurai","Tamil Nadu","625 020","India","IN",{"type":39,"coordinates":97},[98,99],78.11953,9.919,{"lat":99,"lon":98},[102,106],{"name":103,"role":47,"phone":104,"phoneExt":26,"email":105},"NV Prajna, MD DNB FICO","+91 98946 53561","prajna@aravind.org",{"name":103,"role":55,"phone":26,"phoneExt":26,"email":26},{"type":55,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jennifer Rose-Nussbaumer","Professor",[111,113,114],{"name":112,"class":6},"University of Miami",{"name":90,"class":6},{"name":73,"class":6},"100650257","phase-3-rb-pdt-for-fusarium-keratitis-the-lumiere-study-100650257",false,"NCT07743489","RB-PDT for Fusarium Keratitis: The LUMIERE Study","Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)","Inclusion Criteria:\n\n* Presence of culture positive fusarium fungal keratitis\n* Age over 18 years\n* Moderate to severe vision loss, defined as Snellen visual acuity of 20\u002F40 (6\u002F12) to 20\u002F400 (6\u002F120)\n* Corneal thickness ≥350 µm, as measured on AS-OCT\n* Basic understanding of the study as determined by the physician\n* Commitment to return for follow up visits\n\nExclusion Criteria:\n\n* History of hypersensitivity to Rose Bengal\n* Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain)\n* History of intraocular surgery within the last three months\\*\n* Impending or frank perforation at recruitment\n* Involvement of sclera at presentation\n* Presence of desmestocele at recruitment\n* Non-infectious or autoimmune keratitis\n* History of corneal transplantation\n* Pinhole visual acuity worse than 20\u002F200 in the unaffected eye\n* Participants who are decisionally and\u002For cognitively impaired","ALL","18 Years",{"count":125,"type":126},434,"ESTIMATED","INTERVENTIONAL",[129],"PHASE3","This is a multicenter trial with recruitment planned at ophthalmology clinics specializing in corneal diseases in India, Brazil, and at Stanford University and Bascom Palmer Eye Institute in the United States. Fusarium keratitis is common in tropical and subtropical regions like Florida, India and Brazil, which will facilitate access to the required number of participants. The study aims to recruit a total of 434 participants (217 per group).",[132],"Fusarium Keratitis",[134,135,136],"fusarium keratitis","rose bengal","RB-PDT","NOT_YET_RECRUITING","2026-08-13",{"date":140,"type":141},"2026-08-17","ACTUAL",{"date":143,"type":126},"2027-01",{"date":145,"type":126},"2030-01",{"name":5,"class":6},4]