Dry Eye Syndromes Clinical Trial
Official title:
The Feasibility of Fingerprick Autologous Blood (FAB) As a Novel Treatment for Severe Dry Eye Disease (DED)
Dry eye disease (DED) is an umbrella term encompassing a range of diseases estimated to affect 14% of all adults aged 48 to 91. If left untreated, DED can lead to severe reduction in the quality of life of the sufferer. It can also cause loss of vision, pain in response to light, painful recurring stabbing sensations, and the feeling of grit in the affected eye(s). No curative agents for DED exist. Available conventional treatment options for DED such as artificial tears often only alleviate symptoms, have limited effectiveness, and in most cases patients may fail to respond; although the exact rate of treatment failure is unavailable in the published literature. Crudely, human tears with its vast constituents is essentially filtered blood and as such is an obvious source for a "tear mimic" containing the substances of tears. Blood, and several blood derived products, including autologous serum, have been studied as tear substitute candidates. This study proposes to test the use of finger prick autologous blood (FAB) technique in which whole blood is applied to the eye from a cleaned finger.
Autologous serum (AS) eye drops have been found in uncontrolled trials to be beneficial in
DED patient by improving the ocular surface and reducing symptoms. Obtaining autologous serum
requires frequent drawing of blood from the patient— a feature that excludes patients with
anaemia or heart failure from using AS. Furthermore it also appears that 100% autologous
serum is more beneficial than 50% serum and requires larger volumes of blood and/or more
frequent venesection. Patients using AS also require access to a fridge as the product needs
to be stored at low temperatures; a factor that is likely to be inconvenient for patients. In
addition, AS is obtained by processing clotted blood which is often too expensive for the
health service to consistently purchase, given the initial cost of £1653.56 and subsequent
three-monthly cost of £1131.27 per patient.
The relatively high cost represents the biggest hurdle in the use of AS and is often the
reason for delay or inaccessibility in starting treatment for DED using AS. However, we
propose that finger prick autologous blood may be a simpler, cost-effective and possibly more
acceptable method for treating dry eye disease. For this reason, this study proposes to test
the use of finger prick autologous blood (FAB) technique in which whole blood is applied to
the eye from a cleaned finger.
The proposing team have completed an exploratory study on the use of finger-prick autologous
blood (FAB) for persistent epithelial defects and severe dry eye disease and preliminary
results indicate improvement with no adverse events reported. The exploratory study included
16 patients with a diagnosis of severe to moderate dry eye syndrome and used the FAB method
for treatment. The findings of the study demonstrated mean improvements in visual acuity,
Oxford corneal staining grade, tear breakup time, Schirmer's test and dry eye disease
questionnaire score. The response rate from participants was good with only a single patient
who met the inclusion criteria not wishing to participate in the trial on the advice of their
general practitioner. Both the amount of staining (indicating inflammation and ocular surface
damage) and their DED questionnaire scores (indicating severity of their symptoms and impact
on quality of life) showed mean improvement which reached statistical significance.
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