Cross-Linking Assisted Infection Reduction (CLAIR): A Randomized Clinical Trial Evaluating the Effect of Adjuvant Cross-Linking on Bacterial Keratitis.
Cornea
; 40(7): 837-841, 2021 Jul 01.
Article
em En
| MEDLINE
| ID: mdl-33079921
ABSTRACT
PURPOSE:
To determine whether there is a benefit to adjuvant corneal cross-linking (CXL) for bacterial keratitis.METHODS:
This is an outcome-masked, randomized controlled clinical trial. Consecutive patients presenting with a smear-positive bacterial ulcer at Aravind Eye Hospitals at Madurai, Pondicherry, and Coimbatore in India were enrolled. Study eyes were randomized to topical moxifloxacin 0.5% or topical moxifloxacin 0.5% plus CXL. The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle corrected visual acuity at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events.RESULTS:
Those randomized to CXL had 0.60 decreased odds of culture positivity at 24 hours (95% confidence interval [CI] 0.10-3.50; P = 0.65), 0.9 logarithm of the minimum angle of resolution lines worse visual acuity (95% CI -2.8 to 4.6; P = 0.63), and 0.41-mm larger scar size (95% CI -0.48 to 1.30; P = 0.38) at 3 months. We note fewer corneal perforations or need for therapeutic penetrating keratoplasty in the CXL group.CONCLUSIONS:
We were unable to confirm a benefit to adjuvant CXL in the primary treatment of moderate bacterial keratitis. However, CXL may reduce culture positivity and complication rates; therefore, a larger trial to fully evaluate this is warranted. TRIAL REGISTRATION NCT02570321.
Texto completo:
1
Coleções:
01-internacional
Temas:
Geral
Base de dados:
MEDLINE
Assunto principal:
Fotoquimioterapia
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Infecções Oculares Bacterianas
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Úlcera da Córnea
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Fármacos Fotossensibilizantes
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Reagentes de Ligações Cruzadas
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Cornea
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Índia