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.

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. - In: INTERNATIONAL OPHTHALMOLOGY. - ISSN 0165-5701. - 43:7(2023), pp. 2315-2328. [10.1007/s10792-022-02628-4]

A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus. The Argo protocol

Vestri, Annarita;Alunni Fegatelli, Danilo;Serrao, Sebastiano;
2023

Abstract

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.
2023
corneal cross-linking; keratoconus; ribofravin; theranostics
01 Pubblicazione su rivista::01a Articolo in rivista
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. - In: INTERNATIONAL OPHTHALMOLOGY. - ISSN 0165-5701. - 43:7(2023), pp. 2315-2328. [10.1007/s10792-022-02628-4]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1700332
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