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

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/cm2 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 Kmax 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 Kmax 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.