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

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Eye and Vision 2024年第1期10卷 10-20页

作者： Farhad Hafezi Mohammed Hosny Rohit Shetty Boris Knyazer Shihao Chen Qinmei Wang Hassan Hashemi Emilio A.Torres‑Netto 无 Center for Applied Biotechnology and Molecular Medicine(CABMM) University of ZurichZurichSwitzerland ELZA Institute DietikonSwitzerland. Faculty of Medicine University of GenevaGenevaSwitzerland Department of Ophthalmology Medical University of WenzhouWenzhouChina USC Roski Eye Institute University of Southern California Los AngelesLos AngelesUSA Department of Ophthalmology University of CairoCairoEgypt Narayana Nethralaya Eye Hospital and the Postgraduate Institute of Ophthal‑mology BangaloreIndia Department of Ophthalmology Soroka University Medical CenterBen-Gurion University of the NegevBeershebaIsrael Noor Ophthalmology Research Center Noor Eye HospitalTehranIran University Hospital Zurich ZurichSwitzerland. the pack-cxl Working Group

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

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pack-cxl: Corneal cross-linking in infectious keratitis

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Eye and Vision 2016年第1期3卷 84-88页

作者： David Tabibian Cosimo Mazzotta Farhad Hafezi Laboratory for Ocular Cell Biology University of GenevaGenevaSwitzerland Siena Crosslinking Center Siena University HospitalSienaItaly Department of Ophthalmology University of Southern CaliforniaLos AngelesCAUSA EyeCare Laboratory Research Zurich Associates(ELZA)Institute Webereistrasse 28953 DietikonSwitzerland Department of Ophthalmology Northampton General HospitalNorthamptonUnited Kingdom

Background:Corneal cross-linking(cxl)using ultraviolet light-A(UV-A)and riboflavin is a technique developed in the 1990’s to treat corneal ectatic disorders such as keratoconus.It soon became the new gold standard in multiple countries around the world to halt the progression of this disorder,with good long-term outcomes in keratometry reading and visual acuity.The original Dresden treatment protocol was also later on used to stabilize iatrogenic corneal ectasia appearing after laser-assisted in situ keratomileusis(LASIK)and photorefractive keratectomy(PRK).cxl efficiently strengthened the cornea but was also shown to kill most of the keratocytes within the corneal stroma,later on repopulated by those cells.Review:Ultraviolet-light has long been known for its microbicidal effect,and thus cxl postulated to be able to sterilize the cornea from infectious pathogens.This cytotoxic effect led to the first clinical trials using cxl to treat advanced infectious melting corneal keratitis.Patients treated with this technique showed,in the majority of cases,a stabilization of the melting process and were able to avoid emergentàchaud keratoplasty.Following those primary favorable results,cxl was used to treat beginning bacterial keratitis as a first-line treatment without any adjunctive antibiotics with positive results for most patients.In order to distinguish the use of cxl for infectious keratitis treatment from its use for corneal ectatic disorders,a new term was proposed at the 9th cxl congress in Dublin to rename its use in infections as photoactivated chromophore for infectious keratitis-corneal collagen cross-linking(pack-cxl).Conclusion:pack-cxl is now more frequently used to treat infections from various infectious origins.The original Dresden protocol is still used for this purpose.Careful modifications of this protocol could improve the efficiency of this technique in specific clinical situations regarding certain types of pathogens.

关键词： Infectious Keratitis Corneal cross-linking Keratoconus cxl pack-cxl Corneal ulcer Ultraviolet light A Riboflavin

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