Accelerated and Standard Corneal Cross-Linking Protocols in Patients with Down Syndrome: A Non-inferiority Contralateral
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ORIGINAL RESEARCH
Accelerated and Standard Corneal Cross-Linking Protocols in Patients with Down Syndrome: A Noninferiority Contralateral Randomized Trial Hassan Hashemi . Kazem Amanzadeh . Mohammad Seyedian . Hojjat Zeraati . Cynthia J. Roberts . Shiva Mehravaran . Renato Ambro´sio Jr. . Riccardo Vinciguerra . Paolo Vinciguerra . Soheila Asgari Received: August 10, 2020 / Accepted: September 10, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: To compare the results of an accelerated corneal cross-linking (CXL) protocol (9 mW/cm2, 10 min) with the standard CXL protocol (3 mW/cm2, 30 min) in patients with Down syndrome (DS) who have keratoconus (KC). Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12933461. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40123020-00303-4) contains supplementary material, which is available to authorized users. H. Hashemi K. Amanzadeh S. Asgari (&) Noor Ophthalmology Research Center, Noor Eye Hospital, Tehran, Iran e-mail: [email protected] M. Seyedian Noor Research Center for Ophthalmic Epidemiology, Noor Eye Hospital, Tehran, Iran H. Zeraati Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran C. J. Roberts Department of Ophthalmology and Visual Science, The Ohio State University, Columbus, OH, USA C. J. Roberts Department of Biomedical Engineering, The Ohio State University, Columbus, OH, USA
Methods: Twenty-seven 10- to 20-year-old patients with DS who had bilateral progressive KC were enrolled in a contralateral randomized trial and completed 2 years of follow-up examinations. Fellow eyes were randomly allocated to the accelerated CXL group or the standard CXL group. The main outcome measure was change in maximum keratometry (Kmax) centered on the steepest point (zonal Kmax - 3 mm) with a non-inferiority margin of 1.0 diopter (D). Vision and refraction tests, ophthalmic examinations, and corneal tomography were performed at baseline and at 6, 12, and 24 months after CXL. Failure was defined as an increase of
S. Mehravaran ASCEND Center for Biomedical Research, Morgan State University, Baltimore, MD, USA R. Ambro´sio Jr. Rio de Janeiro Corneal Tomography and Biomechanics Study Group, Rio de Janeiro, RJ, Brazil R. Ambro´sio Jr. Federal University of the State of Rio de Janeiro (UNIRIO), Rio de Janeiro, Brazil R. Vinciguerra Humanitas Sant Pio X Hospital, Milan, Italy P. Vinciguerra Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy P. Vinciguerra Humanitas Clinical and Research, Rozzano, Italy
Ophthalmol Ther
C 1.0 D in zonal Kmax - 3 mm within a 12-month period. Results: The mean age (± standard deviation) of the patients was 15.71 ± 2.40 years. The within-group change in zonal Kmax - 3 mm was not significant after 2 years in either group, and within-group zonal Kmax - 3 mm remained stable. At 2 years after CXL, the mean change in the zonal Kmax - 3 mm was – 0.
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