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A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol

The Assessment of theranostic guided riboflavin/UV-A corneal cross-linking for treatment of keratoconus (ARGO; registration number NCT05457647) clinical trial tests the hypothesis that theranostic-guided riboflavin/UV-A corneal cross-linking (CXL) can provide predictable clinical efficacy for haltin...

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Autores principales: Roszkowska, Anna Maria, Lombardo, Giuseppe, Mencucci, Rita, Scorcia, Vincenzo, Giannaccare, Giuseppe, Vestri, Annarita, Alunni Fegatelli, Danilo, Bernava, Giuseppe Massimo, Serrao, Sebastiano, Lombardo, Marco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Netherlands 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10313539/
https://www.ncbi.nlm.nih.gov/pubmed/36587174
http://dx.doi.org/10.1007/s10792-022-02628-4
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author Roszkowska, Anna Maria
Lombardo, Giuseppe
Mencucci, Rita
Scorcia, Vincenzo
Giannaccare, Giuseppe
Vestri, Annarita
Alunni Fegatelli, Danilo
Bernava, Giuseppe Massimo
Serrao, Sebastiano
Lombardo, Marco
author_facet Roszkowska, Anna Maria
Lombardo, Giuseppe
Mencucci, Rita
Scorcia, Vincenzo
Giannaccare, Giuseppe
Vestri, Annarita
Alunni Fegatelli, Danilo
Bernava, Giuseppe Massimo
Serrao, Sebastiano
Lombardo, Marco
author_sort Roszkowska, Anna Maria
collection PubMed
description The Assessment of theranostic guided riboflavin/UV-A corneal cross-linking for treatment of keratoconus (ARGO; registration number NCT05457647) clinical trial tests the hypothesis that theranostic-guided riboflavin/UV-A corneal cross-linking (CXL) can provide predictable clinical efficacy for halting keratoconus progression, regardless of treatment protocol, i.e., either with or without epithelial removal. Theranostics is an emerging therapeutic paradigm of personalized and precision medicine that enables real-time monitoring of image-guided therapy. In this trial, the theranostic software module of a novel UV-A medical device will be validated in order to confirm its accuracy in estimating corneal cross-linking efficacy in real time. During CXL procedure, the theranostic UV-A medical device will provide the operator with an imaging biomarker, i.e., the theranostic score, which is calculated by non-invasive measurement of corneal riboflavin concentration and its UV-A light mediated photo-degradation. ARGO is a randomized multicenter clinical trial in patients aged between 18 and 40 years with progressive keratoconus aiming to validate the theranostic score by assessing the change of the maximum keratometry point value at 1-year postoperatively. A total of 50 participants will be stratified with allocation ratio 1:1 using a computer-generated stratification plan with blocks in two treatment protocols, such as epithelium-off or epithelium-on CXL. Following treatment, participants will be monitored for 12 months. Assessment of safety and performance of theranostic-guided corneal cross-linking treatment modality will be determined objectively by corneal tomography, corneal endothelial microscopy, visual acuity testing and slit-lamp eye examination.
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spelling pubmed-103135392023-07-02 A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol Roszkowska, Anna Maria Lombardo, Giuseppe Mencucci, Rita Scorcia, Vincenzo Giannaccare, Giuseppe Vestri, Annarita Alunni Fegatelli, Danilo Bernava, Giuseppe Massimo Serrao, Sebastiano Lombardo, Marco Int Ophthalmol Original Paper The Assessment of theranostic guided riboflavin/UV-A corneal cross-linking for treatment of keratoconus (ARGO; registration number NCT05457647) clinical trial tests the hypothesis that theranostic-guided riboflavin/UV-A corneal cross-linking (CXL) can provide predictable clinical efficacy for halting keratoconus progression, regardless of treatment protocol, i.e., either with or without epithelial removal. Theranostics is an emerging therapeutic paradigm of personalized and precision medicine that enables real-time monitoring of image-guided therapy. In this trial, the theranostic software module of a novel UV-A medical device will be validated in order to confirm its accuracy in estimating corneal cross-linking efficacy in real time. During CXL procedure, the theranostic UV-A medical device will provide the operator with an imaging biomarker, i.e., the theranostic score, which is calculated by non-invasive measurement of corneal riboflavin concentration and its UV-A light mediated photo-degradation. ARGO is a randomized multicenter clinical trial in patients aged between 18 and 40 years with progressive keratoconus aiming to validate the theranostic score by assessing the change of the maximum keratometry point value at 1-year postoperatively. A total of 50 participants will be stratified with allocation ratio 1:1 using a computer-generated stratification plan with blocks in two treatment protocols, such as epithelium-off or epithelium-on CXL. Following treatment, participants will be monitored for 12 months. Assessment of safety and performance of theranostic-guided corneal cross-linking treatment modality will be determined objectively by corneal tomography, corneal endothelial microscopy, visual acuity testing and slit-lamp eye examination. Springer Netherlands 2022-12-31 2023 /pmc/articles/PMC10313539/ /pubmed/36587174 http://dx.doi.org/10.1007/s10792-022-02628-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Paper
Roszkowska, Anna Maria
Lombardo, Giuseppe
Mencucci, Rita
Scorcia, Vincenzo
Giannaccare, Giuseppe
Vestri, Annarita
Alunni Fegatelli, Danilo
Bernava, Giuseppe Massimo
Serrao, Sebastiano
Lombardo, Marco
A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol
title A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol
title_full A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol
title_fullStr A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol
title_full_unstemmed A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol
title_short A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol
title_sort randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the argo protocol
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10313539/
https://www.ncbi.nlm.nih.gov/pubmed/36587174
http://dx.doi.org/10.1007/s10792-022-02628-4
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