One-year clinical outcomes of theranostic-guided transepithelial corneal UV therapy for progressive keratoconus

Vollständiger Abstract

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Purpose: To evaluate the efficacy of theranostic-guided transepithelial corneal UV therapy in treatment of progressive keratoconus and the association between theranostic imaging biomarkers and 1-year outcomes. Setting: Careggi hospital and Studio Italiano di Oftalmologia, Italy. Design: Real-world evidence case series. Methods: Fifty-five consecutive patients (55 eyes) were treated using a theranostic UV medical device. A 0.22% riboflavin ophthalmic solution was applied onto the cornea with intact epithelium for 20 minutes followed by UV irradiation at 10 mW/cm 2 for 9 minutes in all cases. The theranostic UV device generated intraoperative imaging biomarkers, the riboflavin score and theranostic score , quantifying corneal riboflavin concentration and photoactivation efficacy, respectively. The device guided surgeons in completing treatment based on real-time biomarker monitoring. Results: Fifty-four patients (54 eyes) completed 1-year follow-up. Treatment was safe and effective, with the predefined riboflavin score (>0.4 d.u.) and theranostic score (≥0.6 d.u.) thresholds accurately identifying K max flattening at 1-year in 93% of cases. Additional riboflavin was required in 21% of eyes (n=12), and 15% additional UV energy was required in 5% of eyes (n=3) to reach the theranostic thresholds, thus precisely adjusting the required dose of riboflavin and UV light for each eye. Mean K max decreased by -1.5±1.5 D (P < 0.001) with clinically significant improvements in both uncorrected and corrected distance visual acuity (P < 0.001). Conclusion: Theranostic-guided corneal UV therapy enables patient-specific modulation of riboflavin dosing and UV-A delivery, optimizing corneal flattening and visual outcomes while minimizing the risk of treatment failure under epithelium-on conditions in progressive keratoconus.