Evidence map›Paper›PMID 39192339›Full record

ArticleTrials2024

A double-masked, sham-controlled trial of rose bengal photodynamic therapy for the treatment of fungal and acanthamoeba keratitis: Rose Bengal Electromagnetic Activation with Green Light for Infection Reduction (REAGIR) study.

N V Prajna, P Lalitha, S Sharma, D de Freitas, A Höfling-Lima, N Varnado, S Abdelrahman, V Cavallino, B F Arnold, T M Lietman and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05110001 (Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05110001 phase3completednot on this map

Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction

TypeinterventionalSponsorUniversity of California, San FranciscoRan2022 to 2025Enrolled330ConditionsAcanthamoeba Keratitis, Fungal KeratitisArmsMoxifloxacin Ophthalmic, Chlorhexidine Gluconate, Natamycin, Rose Bengal, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Rose Bengal-Assisted Photodynamic Antimicrobial Therapy for Keratitis.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2025
    Article
  2. Article
  3. Review
  4. Non-antibiotic management of bacterial keratitis.Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological Society
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

N V PrajnaAravind Eye Hospital, Madurai, India.
P LalithaAravind Eye Hospital, Madurai, India.
S SharmaAravind Eye Hospital, Madurai, India.
D de FreitasFederal University of São Paulo, São Paulo, Brazil.
A Höfling-LimaFederal University of São Paulo, São Paulo, Brazil.
N VarnadoByers Eye Institute, Stanford University, 2452 Watson Ct, Palo Alto, CA, 94303, USA.
S AbdelrahmanFrancis I. Proctor Foundation, University of California, Sao Paulo, Brazil.
V CavallinoFrancis I. Proctor Foundation, University of California, Sao Paulo, Brazil.
B F ArnoldFrancis I. Proctor Foundation, University of California, Sao Paulo, Brazil.
T M LietmanFrancis I. Proctor Foundation, University of California, Sao Paulo, Brazil.
J Rose-NussbaumerFrancis I. Proctor Foundation, University of California, Sao Paulo, Brazil. rosej@stanford.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfectious keratitis secondary to fungus or acanthamoeba often has a poor outcome despite receiving the best available medical therapy. In vitro rose bengal photodynamic therapy (RB-PDT) appears to be effective against fungal and acanthamoeba isolates (Atalay HT et al., Curr Eye Res 43:1322-5, 2018, Arboleda A et al. Am J Ophthalmol 158:64-70, 2014). In one published series, RB-PDT reduced the need for therapeutic penetrating keratoplasty in severe bacterial, fungal, and acanthamoeba keratitis not responsive to medical therapy.

methodsThis international, randomized, sham and placebo controlled 2-arm clinical trial randomizes patients with smear positive fungal and acanthamoeba and smear negative corneal ulcers in a 1:1 fashion to one of two treatment arms: 1) topical antimicrobial plus sham RB-PDT or 2) topical antimicrobial plus RB-PDT. DISCUSSION: We anticipate that RB-PDT will improve best spectacle-corrected visual acuity and also reduce complications such as corneal perforation and the need for therapeutic penetrating keratoplasty. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. Our results will be disseminated via ClinicalTrials.gov website, meetings, and journal publications. Our data will also be available upon reasonable request.

trial registrationNCT, NCT05110001 , Registered on November 5, 2021.

Indexed as

Acanthamoeba KeratitisEye Infections, FungalPhotochemotherapyRandomized Controlled Trials as TopicRose BengalDouble-Blind MethodGreen LightHumansMulticenter Studies as TopicPhotosensitizing AgentsTreatment OutcomeVisual AcuityPhotosensitizing AgentsRose BengalCorneaInfectious keratitisRB-PDT

Identifiers

PMID39192339
PMCPMC11351027

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.