You are being invited to take part in a research study. Before you decide whether or not to take part, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and do not hesitate to ask questions if there is anything that is not clear or if you would like more information. This project forms part of the BSc (Hons) Optometry programme. Thank you for taking the time to consider this study. 

What is the purpose of the study?  

Dry eye is a common problem for many patients who consult their local optometry practice. Symptoms include red eyes, grittiness, itchiness, burning, watery eyes and a general sense of the ocular irritation and discomfort. In 2017, the findings of the Tear Film & Ocular Surface Dry Eye Workshop II (TFOS DEWS II) were published evaluating the epidemiology, aetiology, mechanisms and the management and therapy for dry eye disease. As a result, Lissamine Green, an ocular dye, was advocated in the diagnosis of dry eye. Nonetheless, there continues to be some confusion and controversy over it use or potential use within the UK; and whether this is supported by the regulatory and other professional bodies providing legal indemnity cover for optometrists.  

This uncertainty stems from concern raised previously over the legal status of another widely used ocular dye called fluorescein. Fluorescein strips have long been regulated as medicines in the UK, but they are regulated as medical devices in much of the rest of the EU. In response to lobbying from the profession, the Medicines & Healthcare Products Regulatory Agency (MHRA) has permitted the supply of CE-marked medical device fluorescein strips to the UK market and a consensus statement by the main professional bodies has agreed it is in patients’ interests for optometrists to continue to use fluorescein in practice.  

Despite a similar position being evident with lissamine green strips, and CE-marked strips being available, no legal or professional consensus opinion had been forthcoming, until very recently, which has led to lack of clarity regarding its legal and professional use. This is in contrast to it being widely advocated in the latest research as beneficial in the diagnosis of dry eye and therefore potentially in the patients’ interest.

Why have I been invited to take part?

You have been invited to participate in this study because you are an optometrist or contact lens optician 

Do I have to take part?

Consent will be indicated by submission of the questionnaire. Because you will complete the questionnaire anonymously, you will not be able to withdraw from the project once your questionnaire is submitted. 

Will my taking part in this study be kept confidential? 

All data is anonymised and will be stored securely.  

Who has reviewed this study?

This study has been reviewed by the School of Biomedical Sciences Filter Ethical Committee of the University of Ulster. 

Contact details (Student)

Christina Martin

Email: martin-c59@ulster.ac.uk

Contact Details (Supervisor)
Arnold Cochrane
School of Biomedical Sciences
Ulster University
Coleraine
BT52 1SA
Tel +44 (0)28 7012 3034
E-Mail: ajs.cochrane@ulster.ac.uk

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