AAO 2025: Trial demonstrates safety and efficacy of epithelium-on cross linking

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Ken Beckman, MD, FACS, is a corneal specialist and clinical assistant professor at The Ohio State University. At the 2025 American Academy of Ophthalmology meeting in Orlando, Florida, he presented research on a cross-linking procedure for keratoconus treatment.

The study addressed the critical challenge of maintaining oxygen concentration during the cross-linking process. The research revealed 3 essential components for efficient, aerobic cross-linking: riboflavin, light, and oxygen. To overcome oxygen depletion during treatment, patients were equipped with specialized goggles that maintained oxygen concentration above 90% in the goggle chamber. The phase 3 clinical trial employed a two-to-one ratio of treatment to sham groups. After 12 months, the results were compelling: the treatment group demonstrated a half-diopter flattening, while the sham group showed a half-diopter steepening, achieving the full one-diopter delta between groups.

The procedure's safety profile was exceptional. Unlike traditional epi-off cross-linking, which carries risks such as patient discomfort, infection, delayed wound healing, and potential scarring, this new method showed no serious adverse events. Minor side effects like irritation were observed, but the treatment was overwhelmingly well-tolerated.

Beckman highlighted the procedure's potential to expand treatment eligibility. He suggested that the technique could lower the threshold for treating keratoconus patients, particularly those with thinner corneas or those at risk of surface disease. The key advantage is the preservation of the epithelium, which significantly reduces procedural risks. The study's implications are significant for keratoconus treatment. By maintaining oxygen concentration and preserving the epithelial layer, this innovative cross-linking method offers a safer, more accessible approach to managing the progressive eye condition. Clinicians can consider treating a broader range of patients with increased confidence in the procedure's safety and effectiveness.