Purpose: Evaluation of stability and functional response after riboflavin-UVA–induced cross-linking in a population of patients younger than 18 years with progressive keratoconus after 36 months of follow-up.
Methods: Prospective nonrandomized phase II open trial conducted at the Department of Ophthalmology, Siena University, Italy. The “Siena CXL Pediatrics” trial involved 152 patients aged 18 years or younger (10–18 years) with clinical and instrumental evidence of keratoconus progression. The population was divided into 2 groups according to corneal thickness (>450 and <450 μm) at the time of enrollment. The riboflavin-UVA–induced corneal cross-linking was performed in all patients according to the standard epi-off protocol. Parameters recorded preoperatively and postoperatively were as follows: uncorrected visual acuity, best spectacle–corrected visual acuity, corneal topography and surface aberrometry (CSO Eye Top topographer; Florence, Italy), optical pachometry (Visante OCT; Zeiss Meditec, Jena, Germany), and HRT II confocal microscopy (Rostock Cornea Module, Heidelberg, Germany).
Results: Functional data at 36 months showed an increase of +0.18 and +0.16 Snellen lines for uncorrected visual acuity and best spectacle-corrected visual acuity, respectively, in the thicker group (corneal thickness >450 μm) and +0.14 and +0.15 Snellen lines, respectively, in the thinner group (corneal thickness <450 μm). Patients in the latter group already showed a better and faster functional recovery than the thicker group at 3-month follow-up. Topographic results showed statistically significant improvement in K readings and asymmetry index values. Coma reduction was also statistically significant.
Conclusions: The study demonstrated significant and rapid functional improvement in pediatric patients younger than 18 years with progressive keratoconus, undergoing riboflavin-UVA–induced cross-linking. In pediatric age, a good functional response and keratoconus stability was obtained after corneal cross-linking in a 36-month follow-up.