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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
Sponsor:
Collaborators:
Moorfields Eye Hospital NHS Foundation Trust
The Mater Infirmary Hospital Belfast, UK.
Milton Keynes University Hospital NHS Foundation Trust
Heart of England NHS Trust
University Hospitals Bristol NHS Foundation Trust
Birmingham Midland Eye Centre, UK
Information provided by (Responsible Party):
Bedford Hospital NHS Trust

Tracking Information
First Submitted Date  ICMJE May 2, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date October 13, 2016
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02153515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treating Dry Eyes and Corneal Ulcers With Fingerprick Autologous Blood
Official Title  ICMJE Fingerprick Fresh Blood for Treatment of Chronic Corneal Ulcers, Persistent Epithelial Defects and Dry Eyes
Brief Summary To investigate if fresh finger prick autologous blood (FAB) instead of serum from venesection, is a safe and effective treatment for dry eyes and corneal ulcers/ epithelial defects. Currently there are no studies on the use of whole fresh blood for the treatment of chronic ulcers, persistent epithelial defects or dry eyes. Unpublished case reports indicate that fresh blood can be an effective tool to the treatment of corneal pathology.
Detailed Description

Background Autologous serum is used for chronic ulcers and dry eyes. Currently there are no studies on the use of whole fresh blood for the treatment of chronic ulcers, persistent epithelial defects or dry eyes.

Dry eye syndrome (DES) refers to a common but highly heterogeneous group of ocular surface disorders with varying disease severity, due to lack of sufficient tears or sufficient quality of tears. Corneal and conjunctival studies, using a variety of definitions, have estimated the prevalence of ''significant'' DES to be about 10-20% in the adult population, although fortunately severe DES is less frequent (Hikichi et al., 1995; Bjerrum, 1997; Doughty et al., 1997; Bandeen-Roche et al., 1997; Caffery et al., 1998; McCarty et al., 1998; Schein et al., 1999; Moss et al., 2000; Begley et al., 2002; Chia et al., 2003; Lin et al., 2003; Schaumberg et al., 2003).

Dry eye is usually managed with conventional treatment of artificial tears, punctual plugs, occlusive goggles and bandage contact lenses. In spite of maximal conventional therapy, there is a cohort of patients who have persistent symptoms and signs. This represents a more serious ocular surface disorder with patients having significant visual impairment and disability. Particularly severe dry eye might be managed with contact lenses, botulinum toxin induced ptosis and surgical tarsorrhapy. These treatments are not without their own hazards such as infection from contact lenses, reduced vision from the ptosis or surgical tarsorrhapy, particularly in only seeing eyes.

Corneal ulcers are usually managed with artificial tears, antibiotic ointment, bandage contact lenses and steroids.

Autologous serum eye drops have been found in uncontrolled trials to be beneficial in these patients, improving the ocular surface and reducing symptoms (Poon et al., 2001; Fox et al., 1984; Tsubota et all, 1999;). In addition, impression cytology and in vitro toxicity testing demonstrated that serum drops have reduced toxicity compared with unpreserved hydroxypropylmethylcellulose (Noble et al., 2004; Poon et al., 2001)

Obtaining serum requires frequent venesection with significant amount of blood taken. It is also expensive. The serum is aliquoted into hundreds of bottles with the additional risk of bacterial contamination. It also requires a fridge and storage facilities for these aliquoted bottles at the patient's home. Because of these requirements some patients are excluded, for example patients with anaemia because they are unable to give blood. In addition, often there is a delay in starting the treatment for organizational and / or funding reasons that can be detrimental to the course of the disease, causing unnecessary surgery and corneal melt resulting in perforation with potential loss of the eye. The FAB method could be used immediately for patients who are awaiting conventional treatment for autologous blood. Furthermore it also appears that 100% autologous serum is more beneficial than 50% serum (Poon et al), thereby larger volumes of blood and/or more frequent venesection is required.

Autologous fresh blood is already used subconjunctivally to help heal leaking trabeculectomy blebs (Dinah et al.2010; Biswas et al. 2009; Burnstein et al. 2001; Haynes et al., 1999). Autologous blood is also used to help attach limbal autografts in cases of pterygium (de Wit et al. 2010) and in vitreoretinal macular hole surgery (Lai et al. 2009; Chuang et al. 2010; McCannel et al. 2008; Lai et al.,2005). No adverse effects have been reported in these studies. The object of this study is to investigate if serum via a drop of fresh blood is an effective treatment for dry eye and corneal ulcers which currently require venesected autologous blood and would be particularly useful in the current group of patients in whom venesection is contraindicated.

If shown to be effective this may replace current autologous serum practice and its ease of use and reduced cost may mean that it could be extended to other ocular surface diseases or moderate dry eyes and used earlier in corneal epithelial defects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eyes
  • Sjogren's Disease With Dry Eyes
  • Persistent Corneal Epithelial Defects
  • Chronic Corneal Ulcers
Intervention  ICMJE Other: Your own ( autologous) finger prick of blood produced with a diabetic lancet
Study Arms  ICMJE Experimental: Fingerprick of autologous blood (FAB)
Fingerprick of autologous blood (FAB) four times a day for 2 months
Intervention: Other: Your own ( autologous) finger prick of blood produced with a diabetic lancet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 30, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

For Dry Eyes

  • Patients with symptoms of dry eyes on at least QDS lubricants and who in addition:

    1. Satisfy at least one of the following criteria:

      Break up time (BUT) <5 seconds and Schirmer's test without anaesthesia <5 mm at 5 minutes OR presence of rose bengal /lissamine green or fluorescein staining of the ocular surface OR more than 80% score on OCI due to dry eyes (total score greater than or equal to 29/36)

    2. All patients must have unsuccessfully tried cyclosporine ointment or eye drops and temporary or permanent plugs or been offered punctual plugs and refused.

      For Corneal Ulceration

  • Patients with epithelial defects of at least 2 weeks duration where conventional therapy failed. (Conventional therapy includes [if indicated] lubricants, antibiotic ointment, steroids and therapeutic contact lens wear)
  • Any patient with an epithelial defect of at least 4 weeks' duration that has not completely healed with conventional therapy or who are refusing further conventional therapy. These patients would receive FAB therapy instead of tarsorrhaphy or botulinum toxin induced ptosis.

Exclusion Criteria:

  • Fear of needles and unwillingness to carry out repeat finger pricks
  • Infected finger or systemic infection or on systemic antibiotics for infection.
  • Bleeding disorders and on warfarin anticoagulant therapy
  • Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
  • 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
  • Children (under 16 years old).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153515
Other Study ID Numbers  ICMJE 426/2014/340
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bedford Hospital NHS Trust
Study Sponsor  ICMJE Bedford Hospital NHS Trust
Collaborators  ICMJE
  • Moorfields Eye Hospital NHS Foundation Trust
  • The Mater Infirmary Hospital Belfast, UK.
  • Milton Keynes University Hospital NHS Foundation Trust
  • Heart of England NHS Trust
  • University Hospitals Bristol NHS Foundation Trust
  • Birmingham Midland Eye Centre, UK
Investigators  ICMJE
Study Chair: Anant Sharma, FRCOphth Moorfields Eye Hospital NHS Trust and Bedford Hospital NHS Trust
PRS Account Bedford Hospital NHS Trust
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP