PACK-CXL vs. antimicrobial therapy for bacterial, fungal, and mixed infectious keratitis: a prospective randomized phase 3 trial
Abstract Background Infectious keratitis is a major cause of global blindness. We tested whether standalone photoactivated chromophore corneal cross-linking (PACK-CXL) may be an effective first-line treatment in early to moderate infectious keratitis, compared with standard antimicrobial treatment....
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| Format: | Article |
| Language: | English |
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BMC
2022-01-01
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| Series: | Eye and Vision |
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| Online Access: | https://doi.org/10.1186/s40662-021-00272-0 |
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| author | Farhad Hafezi Mohammed Hosny Rohit Shetty Boris Knyazer Shihao Chen Qinmei Wang Hassan Hashemi Emilio A. Torres-Netto the PACK-CXL Working Group |
| author_facet | Farhad Hafezi Mohammed Hosny Rohit Shetty Boris Knyazer Shihao Chen Qinmei Wang Hassan Hashemi Emilio A. Torres-Netto the PACK-CXL Working Group |
| author_sort | Farhad Hafezi |
| collection | DOAJ |
| description | Abstract Background Infectious keratitis is a major cause of global blindness. We tested whether standalone photoactivated chromophore corneal cross-linking (PACK-CXL) may be an effective first-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 five 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, defined as time to re-epithelialization of the corneal epithelial defect in the absence of inflammatory activity in the anterior chamber and clearance of stromal infiltrates. Treatment success was defined 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 significant difference 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 first-line and standalone treatment of early to moderate infectious keratitis of bacterial or fungal origin. Trial registration This trial is registered at ClinicalTrials.gov, trial registration number: NCT02717871 |
| first_indexed | 2024-04-11T20:47:48Z |
| format | Article |
| id | doaj.art-02da36a437a049918652f6a9e3b86076 |
| institution | Directory Open Access Journal |
| issn | 2326-0254 |
| language | English |
| last_indexed | 2024-04-11T20:47:48Z |
| publishDate | 2022-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Eye and Vision |
| spelling | doaj.art-02da36a437a049918652f6a9e3b860762022-12-22T04:03:57ZengBMCEye and Vision2326-02542022-01-019111110.1186/s40662-021-00272-0PACK-CXL vs. antimicrobial therapy for bacterial, fungal, and mixed infectious keratitis: a prospective randomized phase 3 trialFarhad Hafezi0Mohammed Hosny1Rohit Shetty2Boris Knyazer3Shihao Chen4Qinmei Wang5Hassan Hashemi6Emilio A. Torres-Netto7the PACK-CXL Working GroupCenter for Applied Biotechnology and Molecular Medicine (CABMM), University of ZurichDepartment of Ophthalmology, University of CairoNarayana Nethralaya Eye Hospital and the Postgraduate Institute of OphthalmologyDepartment of Ophthalmology, Soroka University Medical Center, Ben-Gurion University of the NegevDepartment of Ophthalmology, Medical University of WenzhouDepartment of Ophthalmology, Medical University of WenzhouNoor Ophthalmology Research Center, Noor Eye HospitalCenter for Applied Biotechnology and Molecular Medicine (CABMM), University of ZurichAbstract Background Infectious keratitis is a major cause of global blindness. We tested whether standalone photoactivated chromophore corneal cross-linking (PACK-CXL) may be an effective first-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 five 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, defined as time to re-epithelialization of the corneal epithelial defect in the absence of inflammatory activity in the anterior chamber and clearance of stromal infiltrates. Treatment success was defined 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 significant difference 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 first-line and standalone treatment of early to moderate infectious keratitis of bacterial or fungal origin. Trial registration This trial is registered at ClinicalTrials.gov, trial registration number: NCT02717871https://doi.org/10.1186/s40662-021-00272-0Photoactivated chromophoreCorneal cross-linkingInfectious keratitisCorneal meltingPACK-CXL |
| spellingShingle | Farhad Hafezi Mohammed Hosny Rohit Shetty Boris Knyazer Shihao Chen Qinmei Wang Hassan Hashemi Emilio A. Torres-Netto the PACK-CXL Working Group PACK-CXL vs. antimicrobial therapy for bacterial, fungal, and mixed infectious keratitis: a prospective randomized phase 3 trial Eye and Vision Photoactivated chromophore Corneal cross-linking Infectious keratitis Corneal melting PACK-CXL |
| title | PACK-CXL vs. antimicrobial therapy for bacterial, fungal, and mixed infectious keratitis: a prospective randomized phase 3 trial |
| title_full | PACK-CXL vs. antimicrobial therapy for bacterial, fungal, and mixed infectious keratitis: a prospective randomized phase 3 trial |
| title_fullStr | PACK-CXL vs. antimicrobial therapy for bacterial, fungal, and mixed infectious keratitis: a prospective randomized phase 3 trial |
| title_full_unstemmed | PACK-CXL vs. antimicrobial therapy for bacterial, fungal, and mixed infectious keratitis: a prospective randomized phase 3 trial |
| title_short | PACK-CXL vs. antimicrobial therapy for bacterial, fungal, and mixed infectious keratitis: a prospective randomized phase 3 trial |
| title_sort | pack cxl vs antimicrobial therapy for bacterial fungal and mixed infectious keratitis a prospective randomized phase 3 trial |
| topic | Photoactivated chromophore Corneal cross-linking Infectious keratitis Corneal melting PACK-CXL |
| url | https://doi.org/10.1186/s40662-021-00272-0 |
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