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INTRODUCTION: The purpose of this non-comparative, prospective, observational study was to evaluate the post-US Food and Drug Administration approval outcomes of epithelium-off, full-fluence, Dresden protocol corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus (KCN) and post-refractive corneal ectasia at a US academic tertiary medical center. METHODS: This study involved 125 eyes of 97 patients with KCN and 13 eyes of 12 patients with post-refractive ectasia which underwent CXL between November 2016 and September 2019. Best spectacle-corrected visual acuity (BSCVA) and corneal topographic parameters were measured preoperatively, at postoperative month 1 (POM-1), and between postoperative months 3 and 24 (POM 3-24). RESULTS: Best spectacle-corrected visual acuity, flat keratometry, steep keratometry, and mean corneal power worsened at POM-1 (p < 0.01) with a return to preoperative values at POM 3-24. Maximum keratometry (Kmax) steepened at POM-1 and then improved beyond preoperative levels at POM 3-24 (p < 0.01 and p = 0.03, respectively). Pachymetry at the apex and pupil decreased at POM-1 and POM 3-24 (p = 0.03). Pachymetry at the thinnest point decreased at POM-1 and trended toward reduction at POM 3-24 (p < 0.001 and p = 0.06, respectively). Visual and tomographic outcomes were similar between pediatric and adult populations, and between KCN and post-refractive ectasia patients. CONCLUSIONS: Real-world results of CXL in the USA are similar to those reported in prior studies, demonstrating an initial worsening of BSCVA, pachymetry, and keratometry followed by corneal flattening and preservation of visual acuity. Improvements in Kmax and stability in visual acuity were observed over 24 months in children and adults with progressive KCN or post-refractive ectasia.
RESUMO
IMPORTANCE: Little evidence exists for prediction error in iris-sutured intraocular lenses. BACKGROUND: To determine the magnitude of prediction error in iris-sutured intraocular lenses, associated factors and their long-term stability. DESIGN: Retrospective, nonrandomized, noncomparative case series conducted at the Wilmer Eye Institute (Baltimore, Maryland, United States). PARTICIPANTS: Adult patients with subluxated intraocular lenses that underwent iris-suture fixation between January 2000 and December 2014 by a single surgeon. Pregnant women, children (below the age of 18) and cases with follow-up under 1 month were excluded. METHODS: Prediction error was calculated in 60 eyes and survival analysis was performed on 99 eyes. MAIN OUTCOME MEASURES: Prediction error (the difference between the postoperative manifest refraction in spherical equivalent and the spherical equivalent predicted by the Barrett Universal II, Holladay 2 and SRK/T formulas), preoperative and postoperative distance-corrected visual acuity, manifest refraction, frequency of postoperative complications and time until re-subluxation. RESULTS: Mean prediction error using the Barrett formula was -0.35 ± 1.0 D. Higher axial length (≥25.5 mm) was associated with greater prediction error (-0.72 ± 1.11 D vs -0.18 ± 0.91 D, P = .048). Twelve re-subluxations occurred over a mean follow-up period of 30.28 ± 41.86 months. The predicted 50% survival of iris-sutured lenses was 114.25 months. CONCLUSIONS AND RELEVANCE: Iris-suture fixation may require moderate lens power adjustment to compensate for prediction error, especially in eyes with higher axial length. Longer follow-up demonstrates that iris-suture fixation remains a viable technique, yet re-subluxations require routine monitoring of such eyes.
