Ocular immunology and inflammation · 2026
Efficacy of 0.5% Voriconazole Subpalpebral Lavage as Adjunctive Therapy: A Multicenter Prospective Study in Fungal Keratitis Management.
Контролируемое клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Zhou Xingli, Liu Chang, Huang Hai, Liang Weiyan, Zhang Xinghui, Niu Xiaoxia, Cao Yan, Ye Jianzhang, Wang Kehua, Bai Jie, Li Ling, Zhao Lin, Li Shaowei
Аннотация
PURPOSE: To evaluate the efficacy of subpalpebral ocular continuous lavage (SOCL) with 0.5% voriconazole combined with systemic antifungals (SOCL+M) versus systemic antifungals alone (M) in fungal keratitis.
METHODS: This was a multicenter, prospective, non-randomized trial with masked outcome assessment. Treatment allocation-to either subpalpebral 0.5% voriconazole lavage combined with systemic antifungals or systemic antifungals monotherapy-was determined by patient preference and physician recommendation. The study protocol was standardized across sites through centralized training and adherence was monitored with monthly audits. The primary outcome was 3-month cure rate; secondary outcomes included penetrating keratoplasty (PKP) rate, hypopyon resolution time, and corneal parameter changes over one month.
RESULTS: Compared to the M group, the SOCL+M group exhibited a significantly higher cure rate (69.0% vs. 40.7%; OR = 3.23, 95% CI: 1.49-7.03, p = 0.003) and a lower rate of penetrating keratoplasty (0% vs. 10%, p = 0.027) at the 3-month follow-up. The hypopyon resolution time occurred more rapidly in the SOCL+M group (6.79 ± 3.36 days vs. 10.06 ± 3.62 days, p = 0.009). Furthermore, the SOCL+M group showed significantly greater reductions in corneal infiltration, epithelial defect, and fungal density at 1 month compared to the M group (all p < 0.05).
CONCLUSIONS: SOCL represents an innovative adjunctive therapy for fungal keratitis, offering significant clinical advantages including accelerated corneal healing, higher cure rates, and reduced need for therapeutic keratoplasty, with strong translational potential.
METHODS: This was a multicenter, prospective, non-randomized trial with masked outcome assessment. Treatment allocation-to either subpalpebral 0.5% voriconazole lavage combined with systemic antifungals or systemic antifungals monotherapy-was determined by patient preference and physician recommendation. The study protocol was standardized across sites through centralized training and adherence was monitored with monthly audits. The primary outcome was 3-month cure rate; secondary outcomes included penetrating keratoplasty (PKP) rate, hypopyon resolution time, and corneal parameter changes over one month.
RESULTS: Compared to the M group, the SOCL+M group exhibited a significantly higher cure rate (69.0% vs. 40.7%; OR = 3.23, 95% CI: 1.49-7.03, p = 0.003) and a lower rate of penetrating keratoplasty (0% vs. 10%, p = 0.027) at the 3-month follow-up. The hypopyon resolution time occurred more rapidly in the SOCL+M group (6.79 ± 3.36 days vs. 10.06 ± 3.62 days, p = 0.009). Furthermore, the SOCL+M group showed significantly greater reductions in corneal infiltration, epithelial defect, and fungal density at 1 month compared to the M group (all p < 0.05).
CONCLUSIONS: SOCL represents an innovative adjunctive therapy for fungal keratitis, offering significant clinical advantages including accelerated corneal healing, higher cure rates, and reduced need for therapeutic keratoplasty, with strong translational potential.