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

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.

Careggi hospital and Studio Italiano di Oftalmologia, Rome, Italy.

Real-world evidence case series.

55 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.

54 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 dimensionless units) thresholds accurately identifying maximum keratometry index (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 diopters ( P < .001) with clinically significant improvements in both uncorrected and corrected distance visual acuities ( P < .001).

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.