FSE 4: Producing a mobility outcome measure for use in clinical trials for eye disease

Faculty: Science and Engineering

Supervisors: Dr Matthew Timmis, Dr Jasleen Jolly, and Dr Keziah Latham

Interview date: 31 March 2022

This is an exciting opportunity to contribute to the success of clinical trials for new treatments for currently untreatable diseases.

Inherited retinal diseases are the most common cause of untreatable blindness in the UK working-age population (Liew et al., 2014). Until recently there have been no treatments for these conditions, but in the last decade the number of potential treatments for inherited retinal degenerations has increased exponentially. Many treatments target rod-cone dystrophies which initially present with reduced night and peripheral vision, both of which fundamentally impact mobility, a key life skill (Turano et al., 1999).

Patients with inherited retinal diseases report an improvement in mobility following gene therapy treatment. However, no implementable mobility measure has yet been accepted by regulatory bodies (e.g., Food and Drug Administration (FDA)) as an appropriate outcome measure to use in the assessment of retinal disease treatments (Jolly et al., 2019).

Many clinical trials fail due to the use of inappropriate outcome measures. To meet regulatory requirements, any outcome measure must:

• be performed under multiple lighting conditions
• provide a discrete measure representative of daily living skills
• be implementable across multiple worldwide sites
• not need specialist skills to implement
• be analysed independent of testing site.

To date one objective ‘mobility-maze’ (course requiring navigation around and over floor-based obstacles, Chung et al., 2018) has been accredited but requires a space and lighting conditions that can constrain implementation.

In this PhD project, the successful candidate will design and validate a series of alternative mobility tasks that can more readily recreated in test sites worldwide. It is anticipated that the project will involve:

• Development and validation of controlled illumination glasses to reliably produce varying light levels, enabling mobility performance to be assessed in a range of lighting conditions.
• Testing of the controlled illumination glasses using research subjects with visual impairments. This will employ a battery of mobility tests to determine which tasks effectively replicate the key components of the ‘mobility-maze’.
• Expansion to a collaborative multicentre roll with the European Retinal Disease Consortium to test efficacy of mobility tests and mobility measures (objective and subjective). This will use subjects pre- and post- gene therapy for longitudinal assessment of patient mobility.

The project will be supported by an experienced team of supervisors with extensive experience in objective gait analysis in the visually impaired, assessment of visual impairment, retinal genetics, gene therapy, clinical trials, developing and validating outcome measures and appropriate technical expertise.

We welcome applicants from a variety of disciplines with experience of vision research, including optometry, ophthalmology, psychology, rehabilitation work or related. Experience in visual assessment is desirable.

If you would like to discuss this research project prior to application please contact matthew.timmis@aru.ac.uk or jasleen.jolly@aru.ac.uk. We strongly encourage informal enquiries.

Funding notes

This successful applicant for this project will receive a Vice Chancellor’s PhD Scholarship which covers Home tuition fees and provides a UKRI equivalent minimum annual stipend for three years. For 2022/3 this will be £15,609 per year. The award is subject to the successful candidate meeting the scholarship terms and conditions. Please note that the University asserts the right to claim any intellectual property generated by research it funds.

Download the full terms and conditions.