Status:
UNKNOWN
Fingerprick Autologous Blood (FAB) in Severe Dry Eye Disease (DED)
Lead Sponsor:
Bedford Hospital NHS Trust
Collaborating Sponsors:
Anglia Ruskin University
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 li...
Detailed Description
Autologous serum (AS) eye drops have been found in uncontrolled trials to be beneficial in DED patient by improving the ocular surface and reducing symptoms. Obtaining autologous serum requires freque...
Eligibility Criteria
Inclusion
- Patient age ≥ 18 years
- Severe symptomatic dry eye disease diagnosed by: Ocular surface disease index (OSDI) score of greater than 33; OR Oxford Corneal Staining grade 2 or greater; OR Schirmer's without anaesthesia \<5mm at 5 minutes
- Patients on artificial tears and/or lubricating drops/gel two or more times a day
- Patient able to give consent
- Patients able and willing complete the quality of life (QoL) questionnaires required for the study
Exclusion
- Fear of needles
- Unable or not willing to carry out repeat finger pricks
- Patients with infected finger/s or systemic infection or on systemic antibiotics for infection.
- Patients with active ocular infection, active immunological corneal melt, or recurrent corneal erosion.
- Pregnant or breast feeding women
- Previous use of FAB treatment (e.g. from exploratory study)
- Systemic illness causing immune system deficiency
- Graft versus host disease
- Previous use of autologous serum within 3 months
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03395431
Start Date
February 1 2018
End Date
July 1 2019
Last Update
January 10 2018
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