Fingerprick Autologous Blood (FAB) in Mebomian Gland Dysfunction (MGD)
The Use of Fingerprick Autologous Blood (FAB) in the Treatment of Mebomian Gland Dysfunction (MGD)
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 24, 2016
October 1, 2016
2.8 years
August 12, 2016
October 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in clinical symptoms assessed using the OSDI questionnaire
Ocular surface disease index questionnaire (OSDI)
2 months
Secondary Outcomes (1)
Improvement of Meibomian Gland Dysfunction signs assessed using the International Workshop on Meibomian Gland Dysfunction report on grading criteria
2 months
Study Arms (1)
Fingerprick Autologous Blood (FAB)
EXPERIMENTALAssigned treatment with FAB
Interventions
Pricking of cleaned finger using diabetic lancet and applying blood droplet to affected eye. Repeated with separate finger for other affected eye.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2016
First Posted
October 24, 2016
Study Start
November 1, 2016
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
October 24, 2016
Record last verified: 2016-10