The Feasibility of Fingerprick Autologous Blood (FAB) As a Novel Treatment for Severe Dry Eye Disease (DED): Protocol for a Randomised Controlled Trial

Balal, Shafi and Udoh, Arit and Pappas, Yannis and Cook, Erica and Barton, Garry and Hassan, Ali and Hayden, Karen and Bourne, Rupert R. A. and Ahmad, Sajjad and Pardhan, Shahina and Harrison, Michael and Sharma, Benjamin and Wasil, Mohammad and Sharma, Anant (2018) The Feasibility of Fingerprick Autologous Blood (FAB) As a Novel Treatment for Severe Dry Eye Disease (DED): Protocol for a Randomised Controlled Trial. BMJ Open, 8 (10). e026770. ISSN 2044-6055

[img]
Preview
Text
Published Version
Available under the following license: Creative Commons Attribution.

Download (486kB) | Preview
[img] Text
Accepted Version
Restricted to Repository staff only
Available under the following license: Creative Commons Attribution Non-commercial No Derivatives.

Download (1MB)
Official URL: http://dx.doi.org/10.1136/bmjopen-2018-026770

Abstract

Introduction: Patients with severe dry eye disease 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 tears substitutes. This study proposes to test the use of whole, fresh, autologous blood obtained from a fingerprick for treatment of severe dry eye disease. Methods and Analysis: The research team at the two participating sites will approach patients with severe dry eye disease 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 Oxford Corneal Staining Guide), patient pain and symptoms scores (assessed by Ocular Surface Disease Index (OSDI) score), and objective signs of dry eye disease as indicated by visual acuity (assessed by Schirmer’s test, tear breakup 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 NHS and patient (assessed via use of NHS services and privately purchased over the counter treatment related to dry eyes disease) and safety measure of pressure within the eye (assessed by intra ocular pressure (IOP) score). Ethics and Dissemination: This trial is ongoing and received a favourable research ethics opinion from the East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (REC reference: 17/EE/0508). The results of this study will be published in a suitable peer-review journal and also presented at international ophthalmic conferences. This will also be shared with the study participants as well as with relevant patient groups and charities. Trial Registration Number: NCT03395431

Item Type: Journal Article
Keywords: ophthalmology, orbital and lacrimal disorder, clinical trials
Faculty: Faculty of Medical Science
Depositing User: Arit Udoh
Date Deposited: 27 Sep 2018 13:49
Last Modified: 16 Jul 2019 09:30
URI: http://arro.anglia.ac.uk/id/eprint/703623

Actions (login required)

Edit Item Edit Item