Purpose: To evaluate the impact of the FDA approval of corneal crosslinking (CXL) on April 18, 2016, on rates of penetrating keratoplasty (PK) and anterior/lamellar keratoplasty (ALK) for the treatment of keratoconus. Methods: We conducted a retrospective analysis of 18,467 matched patients with keratoconus using the TriNetX US Collaborative Network. Of these, 1823 received a PK before CXL approval (9.76%) and 718 received a PK after approval (3.89%). Risk differences and risk ratios were calculated to assess changes in keratoplasty frequency associated with CXL approval. Results: PK procedures significantly decreased after CXL approval. The PK rate was 9.76% before April 18, 2016, and 3.89% thereafter, corresponding to a risk difference of 5.87% ( P < 0.01) and risk ratio of 2.51 95% confidence interval (CI): 2.31–2.73. Similarly, ALK procedures declined, with a preapproval rate of 3.88% compared with 1.16% postapproval, yielding a risk difference of 2.72% ( P < 0.001) and risk ratio of 3.34 (95% CI: 2.87–3.88). Conclusions: FDA approval of CXL was associated with a marked reduction in PK and ALK procedures among patients with keratoconus in the United States, reflecting a shift in surgical management after CXL adoption.
Sayed et al. (Tue,) studied this question.