Theranostic-Guided Corneal UV Therapy for Progressive Keratoconus: First Real-World Evidence One-Year Clinical Outcomes

Purpose: To assess the efficacy of theranostic-guided corneal UV therapy in progressive keratoconus and the association between theranostic imaging biomarkers and 1-year outcomes. Methods: Seventy-three consecutive patients (73 eyes; mean age 22 ± 6 years) with progressive keratoconus underwent epithelial removal followed by theranostic-guided corneal UV therapy using 0.22% riboflavin ophthalmic solution. Eyes received either 10- or 15-minute preset riboflavin application protocol, followed by UV irradiation at 10 mW/cm2 for 9 minutes. The device generated 2 intraoperative imaging biomarkers: the riboflavin score, estimating stromal riboflavin concentration, and the theranostic score, quantifying UV-A mediated photoactivation. These scores enabled real-time monitoring to guide effective completion of treatment. A multivariate linear regression model evaluated the relationship between theranostic imaging biomarkers, baseline patient characteristics, and 1-year Kmax change. Results: Theranostic-guided treatment was effective and showed 94% concordance with the 1-year Kmax flattening. Eight eyes (11%) required an additional 15% UV energy (1.3 extra minute at 10 mW/cm2) to surpass the theranostic score threshold of 0.60. Mean Kmax decreased by -1.6 ± 1.6 D (P < 0.001), whereas uncorrected distance visual acuity and corrected distance visual acuity improved significantly (P < 0.001). The regression model explained a limited proportion of outcome variance (R2 = 0.239; P = 0.01) and indicated that the riboflavin score had a greater association with Kmax flattening compared with the other variables included in the model. Conclusions: Real-time monitoring of stromal riboflavin permeation and photoactivation enables precise, individualized treatment, enhancing the ability to halt keratoconus progression by tailoring therapeutic effect to each cornea's molecular response.