ESCRS - PO659 - The Assessment Of Theranostics For Corneal Cross-Linking To Treat Progressive Keratoconus From A Randomized Multicenter Clinical Trial

The Assessment Of Theranostics For Corneal Cross-Linking To Treat Progressive Keratoconus From A Randomized Multicenter Clinical Trial

Published 2024 - 42nd Congress of the ESCRS

Reference: PO659 | Type: Free paper | DOI: 10.82333/pkje-gs85

Authors: Anna Maria Roszkowska* 1 , Vincenzo Scorcia 2 , Rita Mencucci 3 , Giuseppe Giannaccare 4 , Giuseppe Lombardo 5 , Sebastiano Serrao 6 , Marco Lombardo 6

1Department of Biomedical ​and Dental Sciences and Morphofunctional Imaging,Università di Messina,Messina,Italy, 2UO Oculistica,Università Magna Graecia di Catanzaro,Catanzaro,Italy, 3SOD Oculistica,Università di FirenzeUniversità di Firenze,Firenze,Italy, 4UO Oculistica,Università di Cagliari,Cagliari,Italy, 5Istituto per i Processi Chimico-Fisici,CNR-IPCF,Messina,Italy, 6Studio Italiano di Oftalmologia,Roma,Italy

Purpose

To validate the ability of theranostic imaging biomarkers generated by a UV-A medical device in assessing the propensity of corneal cross-linking (CXL) in flattening the maximum keratometry (Kmax) index.

Setting

University of Messina, University of Catanzaro and University of Firenze

Methods

Fifty patients with progressive keratoconus were stratified to undergo epithelium-off (epi-Off; 25 eyes) and epithelium-on (epi-On; 25 eyes) CXL protocols using UV-A medical device incorporating theranostic software module. The device used controlled UV-A light for performing CXL as well as for estimating the corneal riboflavin concentration (riboflavin score) and assessing treatment effect (theranostic score) in real time. A 0.22% riboflavin formulation was applied onto the cornea for t=15 minutes and t=20 minutes in epi-Off and epi-On protocols respectively. All eyes underwent 9 minutes UV-A irradiance at 10 mW/cm2.

Results

Accuracy and precision of the theranostic imaging biomarkers in predicting eyes that had more than 0.1 diopter (D) Kmax flattening at 1 year were 91% and 95% respectively. The average Kmax value significantly flattened by -1.5±1.6 D (P < 0.001); both the uncorrected and corrected distance visual acuity improved by a mean of -0.1 LogMAR (P < 0.001). There were no significant changes in endothelial cell density (P = 0.33) and central corneal thickness (P = 0.07) 1 year postoperatively.

Conclusions

The study demonstrated the efficacy of integrating theranostics in a UV-A medical device for the precise and predictive treatment of keratoconus with epi-off and epi-on CXL protocols. Real time measurement of riboflavin and its UV-A light mediated photo-activation in the cornea are the primary variables influencing treatment efficacy.