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

"Declarations Competing interestsRoszkowska AM, Mencucci R, Scorcia V, Giannaccare G, Vestri A, Alunni Fegatelli D, Bernava GM and Serrao S: none.Lombardo M and Lombardo G are co-inventors of the patents IT102016000007349, EP3407920B1 and CN201680080266.9 for theranostic-guided corneal cross-linking. Conflict of interestThe authors Roszkowska AM, Mencucci R, Scorcia V, Giannaccare G, Vestri A, Alunni Fegatelli D, Bernava GM and Serrao S have no relevant financial or non-financial interests to disclose. Lombardo M and Lombardo G are co-inventors of the Patents IT102016000007349, EP3407920B1 and CN201680080266.9 for theranostic-guided corneal cross-linking. Ethical approvalThis 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). Consent to participateInformed consent was obtained from all individual participants included in the clinical study. Consent to publishThe authors affirm that human research participants provided informed consent for publication of the images in Fig. 3. Competing interests Roszkowska AM, Mencucci R, Scorcia V, Giannaccare G, Vestri A, Alunni Fegatelli D, Bernava GM and Serrao S: none.Lombardo M and Lombardo G are co-inventors of the patents IT102016000007349, EP3407920B1 and CN201680080266.9 for theranostic-guided corneal cross-linking. Conflict of interest The authors Roszkowska AM, Mencucci R, Scorcia V, Giannaccare G, Vestri A, Alunni Fegatelli D, Bernava GM and Serrao S have no relevant financial or non-financial interests to disclose. Lombardo M and Lombardo G are co-inventors of the Patents IT102016000007349, EP3407920B1 and CN201680080266.9 for theranostic-guided corneal cross-linking."

"Funding Regensight srl is the promoter and sponsor of the study. Study sponsorship does not influence the scientific, technical and procedural autonomy of the Investigators and Study staff."

"The study is registered at clinicaltrials.gov with registration number NCT05457647 (available at https://clinicaltrials.gov/ct2/show/NCT05457647?term=NCT05457647&draw=2&rank=1); it was approved by the Italian Ministry of Health (Prot. N. DGDMF/I.5.i.m.2/2021/2024 05/01/2022) and ethical 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)."