N Venkatesh Prajna, Prajna S Lalitha, Revathi Rajaraman, Sankalp Sharma, Josephine Christy, Naveen Radhakrishnan, Kunal Mandlik, Ana Luisa Höfling-Lima, Denise de Freitas, Camila Kase, Aileen Miwa Tabuse, Talita Trevizani Rocchetti, Srinivas Sai Suma Maalika Kanchugantla, Nicole E Varnado, Sarah Abdelrahman, Benjamin F Arnold, Thomas Leitman, Jennifer Rose-Nussbaumer
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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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>We were unable to find a benefit of adjuvant RB PDT overall. Future directions may include trying alternative photosensitizers or other treatment algorithms.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":" ","pages":""},"PeriodicalIF":9.5000,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Rose Bengal Electromagnetic Activation with Green Light for Infection Reduction Study: A Randomized Controlled Trial.\",\"authors\":\"N Venkatesh Prajna, Prajna S Lalitha, Revathi Rajaraman, Sankalp Sharma, Josephine Christy, Naveen Radhakrishnan, Kunal Mandlik, Ana Luisa Höfling-Lima, Denise de Freitas, Camila Kase, Aileen Miwa Tabuse, Talita Trevizani Rocchetti, Srinivas Sai Suma Maalika Kanchugantla, Nicole E Varnado, Sarah Abdelrahman, Benjamin F Arnold, Thomas Leitman, Jennifer Rose-Nussbaumer\",\"doi\":\"10.1016/j.ophtha.2025.08.027\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Design: </strong>International, randomized, double-masked, sham-controlled clinical trial.</p><p><strong>Participants: </strong>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.</p><p><strong>Main outcome measures: </strong>The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 6 months. 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引用次数: 0
摘要
目的：探讨玫瑰-孟加拉辅助光动力疗法（RB-PDT）治疗真菌性、棘阿米巴性和涂片/培养阴性感染性角膜炎的疗效。研究设计：这项国际、随机、双盲、假对照临床试验，以1:1的方式将角膜溃疡患者随机分为两组：1)局部抗菌药物加假RB-PDT或2)局部抗菌药物加RB-PDT。主要观察指标：主要观察指标为6个月最佳眼镜矫正视力（BSCVA）。次要结果包括3周和3个月时的BSCVA， 3周、3个月和6个月时的浸润和/或疤痕大小，角膜穿孔（CP）和/或治疗性穿透性角膜移植术（TPK）率，微生物治愈率。结果：共纳入330例患者。分离的微生物包括丝状真菌（N=301, 91%）、棘阿米巴（N=10, 3%）和培养/涂片阴性（N=19, 6%）。在6个月时，没有证据表明RB-PDT与sham相比对BSCVA有益处（-0.0004;95% CI -0.13至0.13；P=0.62）。有证据表明，治疗组与真菌之间在BSCVA方面存在统计学上显著的相互作用（P=0.02）。RB-PDT改善镰孢菌感染组BSCVA（差异= -0.17 logMAR, 95% CI -0.37 ~ 0.03），但恶化曲霉菌感染组BSCVA（差异= 0.39 95% CI -0.03 ~ 0.80 logMAR）。RB-PDT组在3周时疤痕大小小0.45 mm (95% CI -0.76至-0.15；P=0.004)，但在3个月和6个月时，这一发现不再具有统计学意义。两组之间的CP/TPK率和微生物治愈率没有差异。结论：我们总体上没有发现辅助RB-PDT的益处。未来的方向可能包括尝试替代光敏剂和/或其他治疗算法。
Rose Bengal Electromagnetic Activation with Green Light for Infection Reduction Study: A Randomized Controlled Trial.
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.
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.
期刊介绍：
The journal Ophthalmology, from the American Academy of Ophthalmology, contributes to society by publishing research in clinical and basic science related to vision.It upholds excellence through unbiased peer-review, fostering innovation, promoting discovery, and encouraging lifelong learning.
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