Autologous Blood Treatment for Ocular Surface Disease

NCT03659955 | Completed

• 1 other identifier: L17047
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Surface Disease

Keywords

Dry eye; Ocular surface; Autologous blood

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Autologous blood

EXPERIMENTAL

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

Interventions

Autologous blood applied to dry eye OTHER

See previous description for the study arm.

Autologous blood

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Lanarkshire: lead
• Chief Scientist Office of the Scottish Government: collaborator
• NHS Research Scotland: collaborator

Study Sites (1)

Hairmyres Hospital

East Kilbride, Lanarkshire, G75 8RG, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Douglas Lyall, FRCOphth

  NHS Lanarkshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Cross sectional study

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: November 7, 2017
• Primary Completion: October 3, 2018
• Study Completion: March 14, 2019
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)