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Purpose To evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus. Design Prospective, randomized, multicenter, controlled clinical trial. Participants Patients with progressive keratoconus (n = 205). Methods The treatment group underwent standard CXL and the sham control group received riboflavin alone without removal of the epithelium. Main Outcome Measures 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. Results 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. Corneal haze was the most frequently reported CXL-related adverse finding. There were no significant changes in endothelial cell count 1 year after treatment. Conclusions Corneal collagen crosslinking was effective in improving the maximum keratometry value, CDVA, and UCVA in eyes with progressive keratoconus 1 year after treatment, with an excellent safety profile. Corneal collagen crosslinking affords the keratoconic patient an important new option to decrease progression of this ectatic corneal process. [ABSTRACT FROM AUTHOR]

Objective: To document the 1-year safety, efficacy, and stability results of 355 eyes treated in the multicenter study of conductive keratoplasty (CK) used to correct low to moderate hyperopia., Design: Nonrandomized comparative (self-controlled) trial., Participants: Twenty surgeons at 13 centers performed CK on the eyes of all patients enrolled in a multicenter, 2-year, U.S. phase III clinical trial. Treated eyes had +0.75 to +3.00 diopters (D) of hyperopia and < or =0.75 D of cylinder. Patients were 40 years of age or older., Intervention: Low-energy, high-frequency current was applied directly into the peripheral corneal stroma through a delivery tip inserted at 8 to 32 treatment spots. The number of treatment spots was increased for increasing levels of hyperopia, but the amount of radiofrequency energy remained constant. Emmetropia was intended. All eyes were treated once (there were no retreatments)., Main Outcome Measures: Data from 355 eyes with 1 year of follow-up were analyzed for safety and stability, and data from 318 eyes were analyzed for efficacy and predictability, as well as stability and safety. All patients reported on satisfaction and quality of vision after surgery., Results: At 1 year, uncorrected visual acuity was < or =20/20 in 56%, < or =20/25 in 75%, and < or =20/40 in 92% of eyes. The manifest refractive spherical equivalent refraction was within 0.50 D in 63%, within +/-1.00 D in 89%, and within +/-2.00 D in 99%. Seven of 355 eyes lost 2 lines of best spectacle-corrected visual acuity at 1 year, but no eye lost >2 lines. One eye of 355 had induced cylinder of >2.00 D. The cycloplegic refractive spherical equivalent changed a mean of 0.25 +/- 0.50 D between months 3 and 6, 0.11 +/- 0.41 D between months 6 and 9, and 0.11 +/- 0.35 D between months 9 and 12. Refractive stability seemed to be attained by 6 months and remained stable through 12 months. Histology and confocal microscopy showed deep penetration of the treatment into the stroma. Endothelial cell counts were not changed by the treatment., Conclusions: CK seems to be safe, effective, and stable for correcting low to moderate spherical hyperopia in patients 40 years old or older. Treatment penetration is deep and cylindrical in shape, and it does not damage the corneal endothelium. Uncorrected visual acuity, predictability, and stability are as good as or better than those obtained with other techniques used to correct hyperopia.