PACK-CXL vs.antimicrobial therapy for bacterial,fungal,and mixed infectious keratitis:a prospective randomized phase 3 trial  

作　　者：Farhad Hafezi Mohammed Hosny Rohit Shetty Boris Knyazer Shihao Chen Qinmei Wang Hassan Hashemi Emilio A.Torres‑Netto 无 

机构地区：[1]Center for Applied Biotechnology and Molecular Medicine(CABMM),University of Zurich,Zurich,Switzerland [2]ELZA Institute,Dietikon,Switzerland. [3]Faculty of Medicine,University of Geneva,Geneva,Switzerland [4]Department of Ophthalmology,Medical University of Wenzhou,Wenzhou,China [5]USC Roski Eye Institute,University of Southern California Los Angeles,Los Angeles,USA [6]Department of Ophthalmology,University of Cairo,Cairo,Egypt [7]Narayana Nethralaya Eye Hospital and the Postgraduate Institute of Ophthal‑mology,Bangalore,India [8]Department of Ophthalmology,Soroka University Medical Center,Ben-Gurion University of the Negev,Beersheba,Israel [9]Noor Ophthalmology Research Center,Noor Eye Hospital,Tehran,Iran [10]University Hospital Zurich,Zurich,Switzerland. [11]the PACK-CXL Working Group

出　　处：《Eye and Vision》2024年第1期10-20,共11页眼视光学杂志（英文）

摘　　要：Background:Infectious keratitis is a major cause of global blindness.We tested whether standalone photoactivated chromophore corneal cross-linking(PACK-CXL)may be an efective frst-line treatment in early to moderate infectious keratitis,compared with standard antimicrobial treatment.Methods:This is a randomized,controlled,multinational phase 3 clinical trial.Participants in fve centers in Egypt,India,Iran,Israel,and China,aged≥18 years,with infectious keratitis of presumed bacterial,fungal,or mixed origin,were randomly assigned(1:1)to PACK-CXL,or antimicrobial therapy.Outcomes measures included healing,defned as time to re-epithelialization of the corneal epithelial defect in the absence of infammatory activity in the anterior chamber and clearance of stromal infltrates.Treatment success was defned as the complete resolution of signs of infection.Results:Between July 21,2016,and March 4,2020,participants were randomly assigned to receive PACK-CXL(n=18)or antimicrobial therapy per American Academy of Ophthalmology(AAO)guidelines(n=21).No participants were lost to follow-up.Four eyes were excluded from the epithelialization time analysis due to treatment failure:two in the antimicrobial therapy group,and two in the PACK-CXL group.Success rates were 88.9%(16/18 patients)in the PACK-CXL group and 90.5%(19/21 patients)in the medication group.There was no signifcant diference in time to complete corneal re-epithelialization(P=0.828)between both treatment groups.Conclusions:PACK-CXL may be an alternative to antimicrobial drugs for frst-line and standalone treatment of early to moderate infectious keratitis of bacterial or fungal origin.

关 键 词：Photoactivated chromophore Corneal cross-linking Infectious keratitis Corneal melting PACK-CXL 

分 类 号：R772.21[医药卫生—眼科]