Treating Dry Eyes and Corneal Ulcers With Fingerprick Autologous Blood (FAB)
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|ClinicalTrials.gov Identifier: NCT02153515|
Recruitment Status : Unknown
Verified October 2016 by Bedford Hospital NHS Trust.
Recruitment status was: Enrolling by invitation
First Posted : June 3, 2014
Last Update Posted : October 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dry Eyes Sjogren's Disease With Dry Eyes Persistent Corneal Epithelial Defects Chronic Corneal Ulcers||Other: Your own ( autologous) finger prick of blood produced with a diabetic lancet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fingerprick Fresh Blood for Treatment of Chronic Corneal Ulcers, Persistent Epithelial Defects and Dry Eyes|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||November 2017|
Experimental: Fingerprick of autologous blood (FAB)
Fingerprick of autologous blood (FAB) four times a day for 2 months
Other: Your own ( autologous) finger prick of blood produced with a diabetic lancet
- Corneal ulcers / epithelial defects: Ulcers to heal within 4 weeks. Dry eyes: To improve signs (corneal and conjunctival staining, Schirmer's test, tear break up time ) or symptoms ( ocular comfort index questionnaire) [ Time Frame: One month for corneal ulcers. Dry eyes 2 months. ]
Follow ups are 3 days, 2 weeks , 4 weeks and 2 months after commencing treatment. Then again 1 month after stopping treatment.
Criteria to stop treatment based on patient safety such as finger infection in protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153515
|Moorfields Eye Centre at Bedford Hospital NHS Trust|
|Bedford, Bedfordshire, United Kingdom, MK42 9DJ|
|Study Chair:||Anant Sharma, FRCOphth||Moorfields Eye Hospital NHS Trust and Bedford Hospital NHS Trust|