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      A Prospective, Comparative, Clinical Study to Evaluate the Safety and Efficacy of Two Different 0.1% Riboflavin Solutions Used in Collagen Crosslinking Treatment for Patients with Keratoconus

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          Abstract

          Purpose

          To compare the safety and efficacy of 0.1% riboflavin in two different solutions which is used in corneal collagen crosslinking (CXL) for the treatment of keratoconus.

          Methods

          This was a prospective, randomized, comparison study which included 100 eyes of 61 patients with progressive keratoconus who underwent CXL with riboflavin 0.1% solution as a photosensitizer, using the standard Dresden protocol of using 3mW/cm 2 UV-A irradiation for 30 minutes which corresponds to a total energy of 5.4 J/cm 2. The recruited patients were divided into 2 groups ie, Flavin Group and Peschke-D group by computer generated randomization. Postoperative examinations were conducted on 1 day, 1 month, 3 months, 6 months and 12 months after the crosslinking.

          Results

          For both groups, the mean manifest spherical equivalent (SE), astigmatism, best corrected distance visual acuity, keratometry values, thinnest pachymetry values, demarcation line depth and endothelial cell density preoperatively and at postoperative 12 months were comparable with no statistically significant differences. At 12 months postoperatively, 62% of eyes in the Flavin group, and 68% of eyes in the Peschke-D group had postoperative manifest SE of within ± 1.00 D. During UV-A exposure, the cornea in the Flavin group showed intraoperative thinning of 112 microns (27%) as compared with a thinning of 108.12 microns (26.5%) observed in the Peschke group (p=1.67) from the initial pachymetry readings. No eye in either group had any immediate or long-term postop vision threatening complications such as infectious keratitis, corneal melt, non-resolving corneal oedema or endothelial decompensation.

          Conclusion

          Both riboflavin solutions were equally safe and effective in the management of progressive keratoconus, and resulted in similar changes in terms of mean manifest spherical equivalent (SE), astigmatism, best corrected distance visual acuity, keratometry values, thinnest pachymetry values, demarcation line depth and endothelial cell density at the end of 12 months postoperatively.

          Trial Registration Number

          Ctri/2019/11/021841 ( Www.ctri.nic.in ).

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          Most cited references29

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          Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus.

          In animal eyes, a significant increase in corneal biomechanical stiffness has been found after collagen crosslinking by combined riboflavin/ultraviolet-A (UVA) treatment. The aim of the present study was to evaluate the clinical usefulness of riboflavin/UVA-induced collagen crosslinking for bringing the progression of keratoconus to a halt. Prospective, nonrandomized clinical pilot study. Twenty-three eyes of 22 patients with moderate or advanced progressive keratoconus (maximum K value, 48-72 diopters) were included. After central corneal abrasion, photosensitizing riboflavin drops were applied and the eyes exposed to UVA (370 nm, 3 mW/cm(2)) in a 1-cm distance for 30 minutes. Postoperative examinations were performed in 6-month intervals, including visual acuity testing, corneal topography, slit-lamp examination, measurement of endothelial cell density, and photographic documentation. The follow-up time was between 3 months and 4 years. In all treated eyes, the progression of keratoconus was at least stopped. In 16 eyes (70%) regression with a reduction of the maximal keratometry readings by 2.01 diopters and of the refractive error by 1.14 diopters was found. Corneal and lens transparency, endothelial cell density, and intraocular pressure remained unchanged. Visual acuity improved slightly in 15 eyes (65%). Collagen crosslinking may be a new way for stopping the progression of keratectasia in patients with keratoconus. The need for penetrating keratoplasty might then be significantly reduced in keratoconus. Given the simplicity and minimal costs of the treatment, it might also be well-suited for developing countries. Long-term results are necessary to evaluate the duration of the stiffening effect and to exclude long term side-effects.
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            Transepithelial corneal collagen crosslinking for progressive keratoconus: 24-month clinical results.

            To assess the clinical results of transepithelial collagen crosslinking (CXL) in patients 26 years and younger with progressive keratoconus suitable for epithelium-off (epi-off) CXL.
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              Biomechanical and histological changes after corneal crosslinking with and without epithelial debridement.

              To test the biomechanical efficiency of corneal crosslinking with riboflavin without epithelial debridement (C3-R). Moscow Helmholtz Research Institute of Eye Diseases, Moscow, Russia. The left eyes of rabbits were crosslinked using standard crosslinking including epithelial removal (Group 1), using benzalkonium chloride-containing proxymetacaine eyedrops without epithelial removal (Group 2), or using preservative-free oxybuprocaine eyedrops without epithelial removal (Group 3). All left eyes received riboflavin solution and were irradiated with an ultraviolet-A double diode for 30 minutes (irradiance 3 mW/cm(2)). The animals were killed 1 day after crosslinking. Biomechanical and histological analyses were performed. Fourteen eyes were evaluated. There was a statistically significant increase in Young's modulus in Group 1 (102.45%) and in Group 2 (21.30%). In Group 3, no biomechanical changes were measured. Histology showed complete cell loss of keratocytes and endothelium in Group 1 and inhomogeneous keratocyte loss down to 200.0 microm in Group 2. No changes were observed in Group 3. Corneal crosslinking without epithelial debridement reduced the biomechanical effect by approximately one fifth compared with standard crosslinking, probably because of restricted and inhomogeneous stromal distribution of riboflavin. The cytotoxic damage was restricted to 200.0 microm stromal depth, which is an advantage over the standard method. Therefore, C3-R is not recommended for the routine treatment of keratoconus but primarily for cases with a corneal thickness less than 400.0 microm in which standard crosslinking cannot be used without serious risk to the endothelium.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                opth
                clinop
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove
                1177-5467
                1177-5483
                21 June 2021
                2021
                : 15
                : 2607-2617
                Affiliations
                [1 ]Department of Phaco-Refractive Surgery, Nethradhama Superspecialty Eye Hospital , Bangalore, Karnataka, India
                Author notes
                Correspondence: Sheetal Brar Nethradhama Superspeciality Eye Hospital , 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru, Karnataka, 560070, IndiaTel +919591002092 Email brar_sheetal@yahoo.co.in
                Author information
                http://orcid.org/0000-0002-7962-841X
                http://orcid.org/0000-0002-2852-758X
                Article
                313647
                10.2147/OPTH.S313647
                8232965
                34188439
                f9021f4a-2011-401c-890d-e6fb99739908
                © 2021 Brar et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 25 April 2021
                : 28 May 2021
                Page count
                Figures: 9, Tables: 9, References: 29, Pages: 11
                Categories
                Original Research

                Ophthalmology & Optometry
                keratoconus,collagen cross linking,cxl,riboflavin,flavin,peschke
                Ophthalmology & Optometry
                keratoconus, collagen cross linking, cxl, riboflavin, flavin, peschke

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