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Completed

NCT Number: NCT03659955

Autologous Blood Treatment for Ocular Surface Disease

In this study, we aim to determine the efficacy of autologous blood as an alternative to autologous serum eye drops (ASE) in people with severe dry eyes and ocular surface inflammation. ASE are drops manufactured from the patient's own blood. Perceived benefits are that human blood contains multiple components that are beneficial to healing and maintaining a healthy ocular surface, including epidermal growth factor, and transforming growth factor β, in addition to fibronectin, vitamin A, and various growth factors. We wish to assess whether administering autologous blood directly to their eye would also be an effective treatment in the management of severe dry eye. It will be the first study analysing the potential benefits of this relatively novel treatment in Scotland and will consider its role in treating an important debilitating condition.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hairmyres Hospital

East Kilbride, Lanarkshire, G75 8RG, United Kingdom

About this study

The surface of the eye, including the cornea, is dependent on the tear film to protect it. An adequate tear film prevents epithelial breakdown, ulceration and secondary infection. The continual regeneration of the corneal epithelium is supported by various components that reside in human tears, such as growth factors, vitamins, electrolytes and neuropeptides. There are various ocular conditions that can lead to a deficiency in any of these tear constituents and can result in excessive surface dryness. This can lead to corneal surface breakdown, non-healing ulceration, secondary infection, globe perforation and sight loss, in addition to severe pain for patients, all of which can have a significant negative impact on a patient's quality of life. First line therapy in the treatment of tear deficiency is in the form of ocular lubricants. Multiple formulations are available in drop, gel and ointment form. Lubricants act as barriers in one form or another to protect the epithelial surface from mechanical trauma. However, in the presence of an unhealthy tear film or corneal epithelial surface, barrier protection alone is inadequate to promote surface regeneration and wound healing. Therefore, even the use of frequent and continual ocular lubricants may be of no benefit to patients with severe ocular surface disease (OSD).

In this study, we aim to determine the efficacy of autologous blood as an alternative to autologous serum eye drops (ASE) in people with severe dry eyes and ocular surface inflammation. ASE are drops manufactured from the patient's own blood. Perceived benefits are that human blood contains multiple components that are beneficial to healing and maintaining a healthy ocular surface, including epidermal growth factor, and transforming growth factor β, in addition to fibronectin, vitamin A, and various growth factors. We wish to assess whether administering autologous blood directly to their eye would also be an effective treatment in the management of severe dry eye. It will be the first study analysing the potential benefits of this relatively novel treatment in Scotland and will consider its role in treating an important debilitating condition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known dry eye and ocular surface disease with or without persistent epithelial defect.
  • No improvement in clinical condition after minimum of six months treatment with conventional ocular lubricants.
  • No improvement in clinical condition after treatment of all other potential sources of ocular surface disease, including localised and systemic inflammatory disease.
  • All topical treatments for dry eye and any other pre-existing ocular conditions are preservative free.
  • Patient has capacity to consent to participate in study and to be taught how to administer blood sample.
  • Patients aged between 18-100 years.

Exclusion criteria

  • Physical disability preventing patient performing needlestick blood sampling.
  • Concurrent ocular infection.
  • Globe perforation.
  • Patients with known blood borne infections.
  • Patients without capacity to consent to participate in the study.

Treatment and study plan

Autologous blood applied to dry eye

Other

See previous description for the study arm.

Primary outcomes

  1. Ocular surface staining score

    Time frame: 12 months

    To evaluate if the use of autologous blood as described in this study will improve the health of the ocular surface as measured by the ocular surface staining score using the Oxford Grading Scheme.

Sponsors and collaborators

Lead sponsor

NHS Lanarkshire

Other Gov

Collaborators

  • Chief Scientist Office of the Scottish Government
  • NHS Research Scotland

Registry information

Official study title

Autologous Blood in the Treatment of Severe Dry Eyes and Ocular Surface Disease

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 6, 2018
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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