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
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
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
NCT ID
NCT02943382
First Posted
August 12, 2016
Last Updated
October 21, 2016
Sponsor
Bedford Hospital NHS Trust
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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