United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment

Ophthalmology
Peter S HershUnited States Crosslinking Study Group

Abstract

To evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus. Prospective, randomized, multicenter, controlled clinical trial. Patients with progressive keratoconus (n = 205). The treatment group underwent standard CXL and the sham control group received riboflavin alone without removal of the epithelium. The primary efficacy criterion was the change over 1 year of topography-derived maximum keratometry value, comparing treatment with control group. Secondary outcomes evaluated were corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), manifest refraction spherical equivalent, endothelial cell count, and adverse events. In the CXL treatment group, the maximum keratometry value decreased by 1.6 diopters (D) from baseline to 1 year, whereas keratoconus continued to progress in the control group. In the treatment group, the maximum keratometry value decreased by 2.0 D or more in 28 eyes (31.4%) and increased by 2.0 D or more in 5 eyes (5.6%). The CDVA improved by an average of 5.7 logarithm of the minimum angle of resolution (logMAR) units. Twenty-three eyes (27.7%) gained and 5 eyes lost (6.0%) 10 logMAR or more. The UDVA improved 4.4 logMAR....Continue Reading

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Citations

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