Title: The feasibility of Fingerprick Autologous Blood (FAB) as a novel treatment for severe dry eye disease (DED): a randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Research Background This research aims to provide an effective, viable treatment for dry eye disease (DED) &ndash; an umbrella term that encompasses a range of diseases which, in total, is estimated to affect 14% of all adults aged 48 to 91. The reported prevalence of severe dry eye reported to be around 7.8% for women and 4.3% for men. If left untreated, DED can lead to a severe reduction in the quality of life of a sufferer and can cause loss of vision, pain in response to light, painful recurring stabbing sensations and the feeling of grit in the affected eye(s). Currently, conventional treatments for dry eyes (artificial tears, punctal plugs and anti-inflammatory drugs) often only alleviate symptoms. Crudely, tears can be described as filtered blood and as such tear substitutes derived from blood, namely autologous serum (AS), have been investigated as a possible treatment for DED. Although several studies have demonstrated efficacy of AS, a Cochrane review concluded that there is &ldquo;inconsistency in its benefit&rdquo;. Additionally, AS is obtained by processing clotted blood which is often too expensive for the health service to consistently purchase, it needs to be stored at low temperatures which may be inconvenient, and frequent blood draws are required &ndash; this excludes patients with anaemia or heart failure from using AS. We propose the use of the fingerprick autologous blood (FAB) technique in which whole blood is applied to the eye from a cleaned finger by the following procedure: The hands are washed with soap and water The required finger is cleaned by wiping it with an alcohol wipe A diabetic lancet is used to prick the required finger The blood droplet formed on the finger is applied directly to the affected eye Steps 2-4 are repeated with a different finger for each affected eye Research Aim The aim of this research is to determine whether the FAB technique (detailed earlier) can be feasibly used as a viable treatment for DED. We aim to evaluate whether the FAB technique can be implemented effectively in multiple NHS clinics throughout the country with adequate fidelity of the technique. Plan of Investigation Patients suffering from DED will be referred to one of five NHS hospitals in the UK (Bedford, Norwich, Birmingham, Milton Keynes and Great Yarmouth). Their eligibility for the study will be assessed by a research fellow at each site and data regarding the severity of their DED will be measured. The participants will be randomised into two groups, each of equal number. The FAB technique will be explained to one half of the participants by a nurse at each site. This group will use the FAB technique alongside conventional treatment for two months, applying blood to the eye four times a day whilst the other group will use the conventional treatment only for two months. The severity of their DED will be assessed in the same way at four and eight weeks for both groups of patients. The study will be single blind &ndash; only the patients and nurse will be aware of the treatment given whilst the research fellow will not. Summary of potential benefit to patients and NHS FAB offers an effective alternative treatment for DED patients who require AS. In addition, it could potentially reduce clinic visits due to fewer follow-ups, fewer eye drop prescriptions and it could result in fewer DED related complications that lead to surgery or blindness, requiring long term care.

Lay abstract: The aim of this feasibility study is to determine how well fingerpricked autologous blood (FAB) can treat patients suffering from dry eye disease (DED). Patients with DED often have limited treatment options; the mainstay of treatment centers around artificial tears. These can be purchased over the counter and include products such as Optrex. It is well known that artificial tears fail to address the extraordinary complexity of human tears. Human tears, with its vast constiuents, is partly, essentially filtered blood. This is why one treatment option for DED (and other eye conditions) is taking the patient's own blood, sending it to a laboratory and filtering off the serum component. This serum is bottled and given to the patient to apply to their eye. Unfortunately, amongst other reasons, many patients do not have access to this as it can cost thousands of pounds every few months. We therefore proposed that a person can simply prick their cleaned finger with a diabetic lancet and apply that fresh blood, with all its constituents, direcly to their eye. We conducted a small exploratory study which has shown that FAB leads to significant improvements in both clinical symptoms and signs at a fraction of the cost. We will conduct a study which compares the use of FAB alongside conventional treatment (artifical tears and lid massage with lid hygiene) to conventional treatment alone. The patients will be randomised to one of the groups; to avoid bias in selecting them for a particular treatment. The researching doctor collecting the results will remain unaware as to which group they belong to, avoiding bias on his/her part. This design was chosen after speaking to several patients from our exploratory study. We aim to inform the public of findings through scientific journals, news articles, and patient groups.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: EYE