{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T03:55:39Z","timestamp":1783482939647,"version":"3.55.0"},"reference-count":32,"publisher":"BMJ","issue":"10","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,9,26]]},"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Patients with severe dry eye disease (DED) often have limited treatment options with standard non-surgical management focused on the use of artificial tears for lubrication and anti-inflammatory drugs. However, artificial tears do not address the extraordinary complexity of human tears. Crudely, human tears with its vast constituents is essentially filtered blood. Blood and several blood-derived products including autologous serum, have been studied as tear substitutes. This study proposes to test the use of whole, fresh, autologous blood obtained from a finger prick for treatment of severe DED.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>The research team at the two participating sites will approach patients with severe DED for this study. Recruitment will take place over 12 months and we expect to recruit 60 patients in total. The primary outcome of this feasibility study is to estimate the proportion of eligible patients approached who consent to and comply with study procedures including treatment regimen and completion of required questionnaires. The secondary outcome measures, although not powered for in this feasibility, include corneal inflammation (assessed by the Oxford corneal staining guide), patient pain and symptoms scores (assessed by the Ocular Surface Disease Index Score), and objective signs of DED as indicated by visual acuity (assessed by Schirmer\u2019s test, tear break-up time, lower and\/or upper tear meniscus height measurement). Other secondary outcomes include patients\u2019 quality of life (assessed using the validated EQ-5D-5L Questionnaire), cost to the National Health Service (NHS) and patient (assessed via use of NHS services and privately purchased over-the-counter treatment related to DED) and safety measure of pressure within the eye (assessed by the Intraocular Pressure (IOP) Score).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This protocol and any subsequent amendments, along with any accompanying material provided to the participant in addition to any advertising material used in this trial have been approved by the East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (REC reference: 17\/EE\/0508). Written approval from the committee was obtained and subsequently submitted to the respective Trust\u2019s Research and Development (R&amp;D) office with final NHS R&amp;D approval obtained. Data obtained from this study will be published in a suitable peer-review journal and will also presented at international ophthalmic conferences including the American Academy of Ophthalmology, the Royal College of Ophthalmology Annual Congress, the Association for Research and Vision and Ophthalmology, and the European Society of Cataract and Refractive Surgery. Information will be provided to patient groups and charities such as the Sjogren\u2019s Society and the Royal National Institute of Blind People. This will also be shared with the study participants as well as with relevant patient groups and charities.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03395431\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\">NCT03395431<\/jats:ext-link>; Pre-results.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-026770","type":"journal-article","created":{"date-parts":[[2018,11,1]],"date-time":"2018-11-01T02:45:42Z","timestamp":1541040342000},"page":"e026770","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct03395431","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"given":"Shafi","family":"Balal","sequence":"first","affiliation":[{"name":"Bedford Hospital NHS Trust, Bedford, UK"},{"name":"Imperial College Healthcare NHS Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arit","family":"Udoh","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit, School of Medicine, Anglia Ruskin University, Chelmsford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yannis","family":"Pappas","sequence":"additional","affiliation":[{"name":"The Research Centre for Health Organisation and Delivery, Institute for Health Research, University of Bedfordshire, Luton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"Cook","sequence":"additional","affiliation":[{"name":"The Research Centre for Health Organisation and Delivery, Institute for Health Research, University of Bedfordshire, Luton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garry","family":"Barton","sequence":"additional","affiliation":[{"name":"Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Hassan","sequence":"additional","affiliation":[{"name":"Bedford Hospital NHS Trust, Bedford, UK"},{"name":"Moorfields Eye Hospital NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Hayden","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit, School of Medicine, Anglia Ruskin University, Chelmsford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupert Richard Alexander","family":"Bourne","sequence":"additional","affiliation":[{"name":"Vision and Eye Research Unit (VERU), School of Medicine, Anglia Ruskin University, Cambridge, UK"},{"name":"Ophthalmology, Cambridge University Hospitals, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sajjad","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Moorfields Eye Hospital NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shahina","family":"Pardhan","sequence":"additional","affiliation":[{"name":"Vision and Eye Research Unit (VERU), School of Medicine, Anglia Ruskin University, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Harrison","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit, School of Medicine, Anglia Ruskin University, Chelmsford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Sharma","sequence":"additional","affiliation":[{"name":"Bedford Hospital NHS Trust, Bedford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad","family":"Wasil","sequence":"additional","affiliation":[{"name":"Bedford Hospital NHS Trust, Bedford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anant","family":"Sharma","sequence":"additional","affiliation":[{"name":"Bedford Hospital NHS Trust, Bedford, UK"},{"name":"Moorfields Eye Hospital NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2018,10,31]]},"reference":[{"key":"2025101814011454000_8.10.e026770.1","doi-asserted-by":"publisher","DOI":"10.1001\/archopht.118.9.1264"},{"key":"2025101814011454000_8.10.e026770.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.anai.2012.01.006"},{"key":"2025101814011454000_8.10.e026770.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0161-6420(03)00462-7"},{"key":"2025101814011454000_8.10.e026770.4","unstructured":"National Eye Research Centre, 2016. 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