Long-Term Outcomes After Corneal Cross-linking for Progressive Keratoconus and Corneal Ectasia: A 10-Year Follow-Up of the Pivotal Study

Objectives:To report on the topographic and visual outcomes 10 years after corneal cross-linking in patients with progressive keratoconus and corneal ectasia after refractive surgery.Methods:Cross-sectional cohort study of an original, prospective, randomized, clinical trial. Patients treated in a single center cornea and refractive surgery practice as part of the U.S. pivotal trials, which led to the Food and Drug Administration approval of corneal cross-linking, were recruited for a 10-year follow-up examination. LogMar lines (LL) of uncorrected visual acuity (UCVA) and best spectacle--corrected visual acuity (BSCVA), maximum keratometry, and thinnest pachymetry were evaluated. In addition, the Belin ABCD progression display was used to determine progression (95% confidence interval) of the anterior curvature, posterior curvature, and corneal thickness of each individual eye included.Results:Nineteen eyes of 13 patients treated with standard cross-linking returned for a 10-year follow-up examination. Mean maximum keratometry changed from 58.2 & PLUSMN;12.0 diopters (D) to 58.3 & PLUSMN;10.1 D, thinnest pachymetry changed from 440.6 & PLUSMN;51.6 & mu;m to 442.3 & PLUSMN;54.4 & mu;m, UCVA changed from 0.79 & PLUSMN;0.42 LL to 0.86 & PLUSMN;0.46 LL, and BSCVA changed from 0.38 & PLUSMN;0.26 LL to 0.33 & PLUSMN;0.34 LL, 10 years after cross-linking. Individually, 68.5% of the entire cohort, 81.8% of keratoconus eyes, and 50% of eyes with corneal ectasia remained topographically stable 10 years after standard cross-linking.Conclusions:In the entire cohort, visual acuity and topography remained stable 10 years after cross-linking. Over the long-term, eyes with keratoconus seem to be more stable than those with corneal ectasia.

Automated summary

This study reports on the topographic and visual outcomes 10 years after corneal cross-linking in patients with progressive keratoconus and corneal ectasia after refractive surgery. The results showed that visual acuity and corneal topography remained stable in the entire cohort 10 years after cross-linking, with eyes with keratoconus being more stable than those with corneal ectasia in the long-term.