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Fingerprick Autologous Blood (FAB) in Mebomian Gland Dysfunction (MGD)

Primary Purpose

Meibomian Gland Dysfunction, Dry Eye Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fingerprick autologous blood (FAB)
Sponsored by
Bedford Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring MGD, Autologous Serum, Meibomian gland dysfunction, Dry eye disease, FAB, Fingerprick autologous blood

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have been diagnosed with meibomian gland dysfunction (based upon lid margin signs and consequent dry eye syndrome) with discomfort which affects their daily life, and who want further treatment and remain symptomatic despite optimum treatment (lid hygiene and massage, tried or are on artificial lubricants at least four times a day and tried or are on oral omega-3 oils).

Exclusion Criteria:

  • Patients who do not have capacity to consent • Children (under 18 years old)
  • Infected finger or systemic infection or on systemic antibiotics for infection
  • Patients with immunodeficiency
  • Infected finger or systemic infection or on systemic antibiotics for infection.
  • Patients with active microbial infection, acute herpes simplex or herpes zoster keratitis, drug toxicity, vitamin A deficiency, or recurrent corneal erosion.
  • Past Ophthalmic history of corneal transplantation.
  • Pregnant or breast feeding women
  • Fear of needles and unwillingness to carry out repeated finger pricks
  • Past or current ocular malignancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Fingerprick Autologous Blood (FAB)

    Arm Description

    Assigned treatment with FAB

    Outcomes

    Primary Outcome Measures

    Improvement in clinical symptoms assessed using the OSDI questionnaire
    Ocular surface disease index questionnaire (OSDI)

    Secondary Outcome Measures

    Improvement of Meibomian Gland Dysfunction signs assessed using the International Workshop on Meibomian Gland Dysfunction report on grading criteria
    To improve signs (grading of MGD) as per 'The International Workshop on Meibomian Gland Dysfunction' report on grading criteria (Tomlinson, 2011)

    Full Information

    First Posted
    August 12, 2016
    Last Updated
    October 21, 2016
    Sponsor
    Bedford Hospital NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02943382
    Brief Title
    Fingerprick Autologous Blood (FAB) in Mebomian Gland Dysfunction (MGD)
    Official Title
    The Use of Fingerprick Autologous Blood (FAB) in the Treatment of Mebomian Gland Dysfunction (MGD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    September 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bedford Hospital NHS Trust

    4. Oversight

    5. Study Description

    Brief Summary
    Dry eye disease remains one of the most common complaints seen in ophthalmic clinics. Causes of dry eye are multifactorial, with the most common cause of evaporative dry eye disease being meibomian gland dysfunction (MGD). Fingerprick autologous blood (FAB) is a novel method which uses a patient's own blood to treat dry eye conditions.
    Detailed Description
    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, the investigators aim to find out 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meibomian Gland Dysfunction, Dry Eye Disease
    Keywords
    MGD, Autologous Serum, Meibomian gland dysfunction, Dry eye disease, FAB, Fingerprick autologous blood

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fingerprick Autologous Blood (FAB)
    Arm Type
    Experimental
    Arm Description
    Assigned treatment with FAB
    Intervention Type
    Other
    Intervention Name(s)
    Fingerprick autologous blood (FAB)
    Intervention Description
    Pricking of cleaned finger using diabetic lancet and applying blood droplet to affected eye. Repeated with separate finger for other affected eye.
    Primary Outcome Measure Information:
    Title
    Improvement in clinical symptoms assessed using the OSDI questionnaire
    Description
    Ocular surface disease index questionnaire (OSDI)
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Improvement of Meibomian Gland Dysfunction signs assessed using the International Workshop on Meibomian Gland Dysfunction report on grading criteria
    Description
    To improve signs (grading of MGD) as per 'The International Workshop on Meibomian Gland Dysfunction' report on grading criteria (Tomlinson, 2011)
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who have been diagnosed with meibomian gland dysfunction (based upon lid margin signs and consequent dry eye syndrome) with discomfort which affects their daily life, and who want further treatment and remain symptomatic despite optimum treatment (lid hygiene and massage, tried or are on artificial lubricants at least four times a day and tried or are on oral omega-3 oils). Exclusion Criteria: Patients who do not have capacity to consent • Children (under 18 years old) Infected finger or systemic infection or on systemic antibiotics for infection Patients with immunodeficiency Infected finger or systemic infection or on systemic antibiotics for infection. Patients with active microbial infection, acute herpes simplex or herpes zoster keratitis, drug toxicity, vitamin A deficiency, or recurrent corneal erosion. Past Ophthalmic history of corneal transplantation. Pregnant or breast feeding women Fear of needles and unwillingness to carry out repeated finger pricks Past or current ocular malignancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anant Sharma, MD
    Phone
    01234
    Email
    anant.sharma@bedfordhospital.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shafi Balal, MBBS
    Phone
    01234
    Email
    shafi.balal@nhs.net

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Fingerprick Autologous Blood (FAB) in Mebomian Gland Dysfunction (MGD)

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