The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial
Cook, Erica Jane
Bourne, Rupert Richard Alexander
AffiliationBedford Hospital NHS Trust
Imperial College Healthcare NHS Trust
Anglia Ruskin University
University of Bedfordshire
University of East Anglia
Moorfields Eye Hospital NHS Foundation Trust
Cambridge University Hospitals
MetadataShow full item record
AbstractThe 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's test, tear break-up time, lower and/or upper tear meniscus height measurement). Other secondary outcomes include patients' 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). 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's Research and Development (R&D) office with final NHS R&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's 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. NCT03395431; Pre-results. 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. METHODS AND ANALYSIS ETHICS AND DISSEMINATION TRIAL REGISTRATION NUMBER INTRODUCTION
CitationBalal S, Udoh A, Pappas Y, Cook E, Barton G, Hassan A, Hayden K, Bourne RRA, Ahmad S, Pardhan S, Harrison M, Sharma B, Wasil M, Sharma A (2018) 'The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial', BMJ Open, 8 (10)
PubMed Central IDPMC6252631
The following license files are associated with this item:
- Creative Commons
Except where otherwise noted, this item's license is described as Green - can archive pre-print and post-print or publisher's version/PDF
- Comparison of treatment efficacy between 100% platelet-rich plasma and 100% serum eye drops in moderate-to-severe dry eye disease: a randomised controlled trial protocol.
- Authors: Jongkhajornpong P, Numthavaj P, Anothaisintawee T, Lekhanont K, McKay G, Attia J, Thakkinstian A
- Issue date: 2021 Jun 30
- Clinical efficacy of diquafosol sodium 3% versus hyaluronic acid 0.1% in patients with dry eye disease after cataract surgery: a protocol for a single-centre, randomised controlled trial.
- Authors: Miura M, Inomata T, Nojiri S, Sung J, Nagao M, Shimazaki J, Midorikawa-Inomata A, Okumura Y, Fujio K, Akasaki Y, Kuwahara M, Huang T, Nakamura M, Iwagami M, Hirosawa K, Fujimoto K, Murakami A
- Issue date: 2022 Jan 31
- Efficacy and safety of acupuncture at a single BL1 acupoint in the treatment of moderate to severe dry eye disease: Protocol for a randomized, controlled trial.
- Authors: Zhang X, Liu Z, Ding W, Zhang J, Shi H, Zhu W
- Issue date: 2018 Jun
- Autologous Serum Eye Drops versus Artificial Tear Drops for Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
- Authors: Wang L, Cao K, Wei Z, Baudouin C, Labbé A, Liang Q
- Issue date: 2020
- Study design and baseline findings from the progression of ocular findings (PROOF) natural history study of dry eye.
- Authors: McDonnell PJ, Pflugfelder SC, Stern ME, Hardten DR, Conway T, Villanueva L, Hollander DA
- Issue date: 2017 Dec 28