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dc.contributor.authorChowdhury, Kashfia
dc.contributor.authorDore, Caroline
dc.contributor.authorBurr, Jennifer M.
dc.contributor.authorBunce, Catey
dc.contributor.authorRaynor, Mathew
dc.contributor.authorEdwards, Matthew
dc.contributor.authorLarkin, Daniel F. P.
dc.date.accessioned2019-12-06T15:30:09Z
dc.date.available2019-12-06T15:30:09Z
dc.date.issued2019-09-12
dc.identifier.citationChowdhury , 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-2018-028761en
dc.identifier.issn2044-6055
dc.identifier.otherPURE: 264079894
dc.identifier.otherPURE UUID: 32480583-9106-44d0-bbcd-fd28f4da4634
dc.identifier.otherWOS: 000497787600130
dc.identifier.otherScopus: 85072150699
dc.identifier.otherORCID: /0000-0002-9478-738X/work/65702579
dc.identifier.urihttp://hdl.handle.net/10023/19087
dc.descriptionThis work was supported by the Efficacy and Mechanism Evaluation Programme (reference 14/23/18), a MRC and NIHR partnership.en
dc.description.abstractIntroduction: 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.
dc.format.extent6
dc.language.isoeng
dc.relation.ispartofBMJ Openen
dc.rightsCopyright © 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/.en
dc.subjectCorneaen
dc.subjectKeratoconusen
dc.subjectProgressionen
dc.subjectCross linkingen
dc.subjectTopographyen
dc.subjectRE Ophthalmologyen
dc.subjectRM Therapeutics. Pharmacologyen
dc.subject3rd-NDASen
dc.subject.lccREen
dc.subject.lccRMen
dc.titleA randomised, controlled, observer-masked trial of corneal cross-linking for progressive keratoconus in children : the KERALINK protocolen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.contributor.institutionUniversity of St Andrews.Population and Behavioural Science Divisionen
dc.identifier.doihttps://doi.org/10.1136/bmjopen-2018-028761
dc.description.statusPeer revieweden


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