Ophthalmology · 2025
Rose Bengal Electromagnetic Activation with Green Light for Infection Reduction Study: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Prajna N Venkatesh, Lalitha Prajna S, Rajaraman Revathi, Sharma Sankalp, Christy Josephine, Radhakrishnan Naveen, Mandlik Kunal, Höfling-Lima Ana Luisa, de Freitas Denise, Kase Camila, Tabuse Aileen Miwa, Rocchetti Talita Trevizani, Suma Maalika Kanchugantla Srinivas Sai, Varnado Nicole E, Abdelrahman Sarah, Arnold Benjamin F, Leitman Thomas, Rose-Nussbaumer Jennifer
Аннотация
PURPOSE: To determine the effect of adjunctive rose bengal (RB) photodynamic therapy (PDT) in the treatment of fungal, Acanthamoeba, and smear- or culture-negative infectious keratitis.
DESIGN: International, randomized, double-masked, sham-controlled clinical trial.
PARTICIPANTS: Patients with corneal ulcers randomized in a 1:1 fashion to 1 of 2 treatment arms: (1) topical antimicrobial therapy plus sham RB PDT or (2) topical antimicrobial therapy plus RB PDT.
MAIN OUTCOME MEASURES: The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included BSCVA at 3 weeks and 3 months; infiltrate, scar size, or both at 3 weeks, 3 months, and 6 months; and corneal perforation (CP), the rate of therapeutic penetrating keratoplasty (TPK), or both; and microbiological cure rate.
RESULTS: Three hundred thirty patients were enrolled. Isolated organisms included filamentous fungus (n = 301 [91%]), Acanthamoeba (n = 10 [3%]), and negative culture or smear findings (n = 19 [6%]). No evidence was found of a benefit of RB PDT versus sham for BSCVA at 6 months (-0.0004; 95% confidence interval [CI], -0.13 to 0.13; P = 0.62). Evidence was found of a statistically significant interaction between treatment arm and fungal organism with regard to BSCVA (P = 0.02). Rose bengal PDT improved BSCVA among eyes with Fusarium infections (difference, -0.17 logarithm of the minimum angle of resolution [logMAR]; 95% CI, -0.37 to 0.03 logMAR), but worsened BSCVA among eyes with Aspergillus infections (difference, 0.39 logMAR; 95% CI, -0.03 to 0.80 logMAR). Scar size was 0.45 mm smaller in the RB PDT group at 3 weeks (95% CI, -0.76 to -0.15 mm; P = 0.004), but this finding was no longer statistically significant at 3 and 6 months. No difference between groups was found in rates of CP, TPK, or microbiological cure.
CONCLUSIONS: We were unable to find a benefit of adjuvant RB PDT overall. Future directions may include trying alternative photosensitizers or other treatment algorithms.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
DESIGN: International, randomized, double-masked, sham-controlled clinical trial.
PARTICIPANTS: Patients with corneal ulcers randomized in a 1:1 fashion to 1 of 2 treatment arms: (1) topical antimicrobial therapy plus sham RB PDT or (2) topical antimicrobial therapy plus RB PDT.
MAIN OUTCOME MEASURES: The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included BSCVA at 3 weeks and 3 months; infiltrate, scar size, or both at 3 weeks, 3 months, and 6 months; and corneal perforation (CP), the rate of therapeutic penetrating keratoplasty (TPK), or both; and microbiological cure rate.
RESULTS: Three hundred thirty patients were enrolled. Isolated organisms included filamentous fungus (n = 301 [91%]), Acanthamoeba (n = 10 [3%]), and negative culture or smear findings (n = 19 [6%]). No evidence was found of a benefit of RB PDT versus sham for BSCVA at 6 months (-0.0004; 95% confidence interval [CI], -0.13 to 0.13; P = 0.62). Evidence was found of a statistically significant interaction between treatment arm and fungal organism with regard to BSCVA (P = 0.02). Rose bengal PDT improved BSCVA among eyes with Fusarium infections (difference, -0.17 logarithm of the minimum angle of resolution [logMAR]; 95% CI, -0.37 to 0.03 logMAR), but worsened BSCVA among eyes with Aspergillus infections (difference, 0.39 logMAR; 95% CI, -0.03 to 0.80 logMAR). Scar size was 0.45 mm smaller in the RB PDT group at 3 weeks (95% CI, -0.76 to -0.15 mm; P = 0.004), but this finding was no longer statistically significant at 3 and 6 months. No difference between groups was found in rates of CP, TPK, or microbiological cure.
CONCLUSIONS: We were unable to find a benefit of adjuvant RB PDT overall. Future directions may include trying alternative photosensitizers or other treatment algorithms.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.