FAB in MGD (v4 - 10.02.17)

  • Research type

    Research Study

  • Full title

    Treating Meibomian Gland Disease (MGD) with Fingerprick Autologous Blood (FAB)

  • IRAS ID

    189243

  • Contact name

    Shafi Balal

  • Contact email

    shafi.balal@nhs.net

  • Sponsor organisation

    Bedford Hospital

  • Clinicaltrials.gov Identifier

    NCT02943382

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    Dry eye disease remains one of the most common complaints seen in ophthalmic clinics, with one in four patients reporting symptoms of the condition (including soreness, foreign body sensation or temporary blurring of vision). Causes of dry eye are multifactorial, with the most common cause of evaporative dry eye disease being meibomian gland dysfunction (MGD).

    A chronic, abnormality of the glands lining the eyelid. MGD results in alteration of the tear film, symptoms of eye irritation, inflammation and ocular surface disease. In those with moderate or severe disease (as defined by symptoms, clinical signs and corneal staining), anti-inflammatory therapy is recommended, with topical steroids or oral tetracyclines. However, both these treatments are accompanied by side effects; topical steroids cause increased intraocular pressure, and predispose to eye infection and cataracts, whilst tetracyclines cause skin phototoxicity.

    Autologous serum drops are used as a treatment for severe dry eyes by providing growth factors and anti-inflammatory mediators to the ocular surface. It is derived from the liquid component of blood, after clotting factors and blood cells have been extracted. Obtaining this carries its own problems: numerous venesections from the patient, fridge storage to prevent bacterial contamination, and individual funding request as it is expensive.

    The growth factors and anti-inflammatory mediators in serum are also present in whole blood; which can be obtained using a finger prick technique as in diabetics, thus bypassing the cost and storage problems associated with autologous serum.

    Finger prick autologous blood (FAB) has shown efficacy and safety in the treatment of severe dry eye syndrome patients and persistent corneal epithelial defects. In this study, we investigate whether FAB is an effective alternative to long-term anti-inflammatories in the treatment of MGD. Patient's with MGD will be recruited from Moorfields Eye clinic at Bedford Hospital. The study will be conducted over 2 years.

  • REC name

    East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

  • REC reference

    16/EE/0549

  • Date of REC Opinion

    12 May 2017

  • REC opinion

    Further Information Favourable Opinion