Autologous Blood Treatment for Ocular Surface Disease

Autologous Blood in the Treatment of Severe Dry Eyes and 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.

Study Overview

• Status: Completed
• Conditions: Ocular Surface Disease
• Intervention / Treatment: Other: Autologous blood applied to dry eye

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lanarkshire
    • East Kilbride, Lanarkshire, United Kingdom, G75 8RG
      • Hairmyres Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous blood; Patients with severe dry eye and ocular surface disease who attend the corneal service within NHS Lanarkshire and who are unresponsive to conservative treatment measures will be considered for treatment of their condition with autologous blood. Intervention is application of autologous blood.	Other: Autologous blood applied to dry eye; See previous description for the study arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular surface staining score	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.	12 months

Collaborators and Investigators

• Sponsor: NHS Lanarkshire
• Collaborators: Chief Scientist Office of the Scottish Government; NHS Research Scotland
• Investigators: Principal Investigator: Douglas Lyall, FRCOphth, NHS Lanarkshire

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): October 3, 2018
• Study Completion (Actual): March 14, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Dry eye; Ocular surface; Autologous blood
• Other Study ID Numbers: L17047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No