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The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial

INTRODUCTION: 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...

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Autores principales: Balal, Shafi, Udoh, Arit, Pappas, Yannis, Cook, Erica, Barton, Garry, Hassan, Ali, Hayden, Karen, Bourne, Rupert Richard Alexander, Ahmad, Sajjad, Pardhan, Shahina, Harrison, Michael, Sharma, Benjamin, Wasil, Mohammad, Sharma, Anant
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252631/
https://www.ncbi.nlm.nih.gov/pubmed/30385451
http://dx.doi.org/10.1136/bmjopen-2018-026770
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author Balal, Shafi
Udoh, Arit
Pappas, Yannis
Cook, Erica
Barton, Garry
Hassan, Ali
Hayden, Karen
Bourne, Rupert Richard Alexander
Ahmad, Sajjad
Pardhan, Shahina
Harrison, Michael
Sharma, Benjamin
Wasil, Mohammad
Sharma, Anant
author_facet Balal, Shafi
Udoh, Arit
Pappas, Yannis
Cook, Erica
Barton, Garry
Hassan, Ali
Hayden, Karen
Bourne, Rupert Richard Alexander
Ahmad, Sajjad
Pardhan, Shahina
Harrison, Michael
Sharma, Benjamin
Wasil, Mohammad
Sharma, Anant
author_sort Balal, Shafi
collection PubMed
description INTRODUCTION: 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: 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’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). ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT03395431; Pre-results.
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spelling pubmed-62526312018-12-11 The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial Balal, Shafi Udoh, Arit Pappas, Yannis Cook, Erica Barton, Garry Hassan, Ali Hayden, Karen Bourne, Rupert Richard Alexander Ahmad, Sajjad Pardhan, Shahina Harrison, Michael Sharma, Benjamin Wasil, Mohammad Sharma, Anant BMJ Open Ophthalmology INTRODUCTION: 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: 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’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). ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT03395431; Pre-results. BMJ Publishing Group 2018-10-31 /pmc/articles/PMC6252631/ /pubmed/30385451 http://dx.doi.org/10.1136/bmjopen-2018-026770 Text en © Author(s) (or their employer(s)) 2018. 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/.
spellingShingle Ophthalmology
Balal, Shafi
Udoh, Arit
Pappas, Yannis
Cook, Erica
Barton, Garry
Hassan, Ali
Hayden, Karen
Bourne, Rupert Richard Alexander
Ahmad, Sajjad
Pardhan, Shahina
Harrison, Michael
Sharma, Benjamin
Wasil, Mohammad
Sharma, Anant
The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial
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
title_full The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial
title_fullStr The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial
title_full_unstemmed The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial
title_short The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial
title_sort feasibility of finger prick autologous blood (fab) as a novel treatment for severe dry eye disease (ded): protocol for a randomised controlled trial
topic Ophthalmology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252631/
https://www.ncbi.nlm.nih.gov/pubmed/30385451
http://dx.doi.org/10.1136/bmjopen-2018-026770
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