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A randomised, controlled, observer-masked trial of corneal cross-linking for progressive keratoconus in children : the KERALINK protocol

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Date
12/09/2019
Author
Chowdhury, Kashfia
Dore, Caroline
Burr, Jennifer M.
Bunce, Catey
Raynor, Mathew
Edwards, Matthew
Larkin, Daniel F. P.
Keywords
Cornea
Keratoconus
Progression
Cross linking
Topography
RE Ophthalmology
RM Therapeutics. Pharmacology
3rd-NDAS
Metadata
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Abstract
Introduction: The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients under 17 years old. KERALINK is a randomised controlled, observer-masked, multicentre trial in progressive keratoconus comparing epithelium-off CXL with standard care, including spectacles or contact lenses as necessary for best-corrected acuity. Methods and analysis: A total of 30 participants will be randomised per group. Eligible participants aged 10-16 years with progressive keratoconus in one or both eyes will be recruited. Following randomisation, participants will be followed up 3-monthly for 18 months. The effect on progression will be determined by K-2 on corneal topography. The primary outcome measure is between-group difference in K-2 at 18 months adjusted for K-2 at baseline examination. Secondary outcomes are the effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events. Patient-reported effects will be explored by questionnaires. Ethics and dissemination Research Ethics Committee Approval was obtained on 30 June 2016 (ref: 14/LO/1937). Current protocol: V.5.0 (08/11/2017). Study findings will be published in peer-reviewed journals.
Citation
Chowdhury , K , Dore , C , Burr , J M , Bunce , C , Raynor , M , Edwards , M & Larkin , D F P 2019 , ' A randomised, controlled, observer-masked trial of corneal cross-linking for progressive keratoconus in children : the KERALINK protocol ' , BMJ Open , vol. 9 , no. 9 , e028761 . https://doi.org/10.1136/bmjopen-2018-028761
Publication
BMJ Open
Status
Peer reviewed
DOI
https://doi.org/10.1136/bmjopen-2018-028761
ISSN
2044-6055
Type
Journal article
Rights
Copyright © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Description
This work was supported by the Efficacy and Mechanism Evaluation Programme (reference 14/23/18), a MRC and NIHR partnership.
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  • University of St Andrews Research
URI
http://hdl.handle.net/10023/19087

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