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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\u00a0years with progressive keratoconus aiming to validate the <jats:italic>theranostic score<\/jats:italic> 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\u00a0months. 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.<\/jats:p>","DOI":"10.1007\/s10792-022-02628-4","type":"journal-article","created":{"date-parts":[[2022,12,31]],"date-time":"2022-12-31T20:02:22Z","timestamp":1672516942000},"page":"2315-2328","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO protocol"],"prefix":"10.1007","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8083-3437","authenticated-orcid":false,"given":"Anna Maria","family":"Roszkowska","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Lombardo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rita","family":"Mencucci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincenzo","family":"Scorcia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Giannaccare","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annarita","family":"Vestri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Danilo","family":"Alunni Fegatelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe Massimo","family":"Bernava","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastiano","family":"Serrao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Lombardo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,12,31]]},"reference":[{"issue":"3","key":"2628_CR1","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1080\/09286586.2020.1804593","volume":"28","author":"BK Armstrong","year":"2021","unstructured":"Armstrong BK, Smith SD, Coc IR, Agarwal P, Mustapha N, Navon S (2021) Screening for keratoconus in a high-risk adolescent population. 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Lombardo M and Lombardo G are co-inventors of the Patents IT102016000007349, EP3407920B1 and CN201680080266.9 for theranostic-guided corneal cross-linking.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committees of Regione Calabria Sezione Area Centro (Prot. N. 358 18\/11\/2021), AOU Gaetano Martino (Prot. N. 101 23\/11\/2021) and Area Vasto Centro (Prot. N. 21250_spe 18\/01\/2022).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the clinical study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The authors affirm that human research participants provided informed consent for publication of the images in Fig.\u00a0.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}}]}}