Fingerprick Autologous Blood (FAB) in Severe Dry Eye Disease

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    233813

  • Contact name

    Anant Sharma

  • Contact email

    anant.sharma@bedfordhospital.nhs.uk

  • Sponsor organisation

    BEDFORD HOSPITAL NHS TRUST

  • Clinicaltrials.gov Identifier

    NCT03395431

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    This study proposes to test the use of whole, fresh, autologous blood as a treatment for severe dry eye disease. 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. 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). The mainstay of non-surgical treatment for DED focuses on the use of artificial tears. It is well known that artificial tears fails to account for the extraordinarily complex composition of the natural tear film. Also, many artificial tears contain preservatives that have been shown to adversely affect the cornea. 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 fingerprick autologous blood (FAB) technique in which whole blood is applied to the eye from a cleaned finger. Autologous fresh blood is already used subconjunctivally to help heal leaking trabeculectomy blebs. It is also used to help attach limbal autografts in cases of pterygium and vitreoretinal macular hole surgery, with no adverse effects reported. The FAB method can be used immediately for patients who are awaiting conventional treatment for autologous blood. The objective of this study is therefore to investigate if serum via a drop of fresh blood is an effective treatment for severe dry eye disease which currently require venesected autologous blood and whether this would be particularly useful in the group of patients in whom venesection is contraindicated or funding is not available.

  • REC name

    East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

  • REC reference

    17/EE/0508

  • Date of REC Opinion

    28 Feb 2018

  • REC opinion

    Further Information Favourable Opinion