Novel Technologies to Measure Vision-related Quality of Life

NCT07489898 | Not Yet Recruiting

• 1 other identifier: A097651
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traditional ways of measuring vision, such as reading letters on an eye chart, do not fully reflect the real-life visual problems experienced by people with eye diseases. Many patients report difficulties with things like contrast, recognising faces, and identifying items whilst shopping - challenges that are not captured by standard clinical tests. As a result, it is hard to understand the true impact of these conditions on everyday life, or to measure how well new treatments are working. Some new treatments for eye diseases have shown promise, but clinical trials have often struggled to show clear benefits. This is largely because the tools used to measure vision changes in trials are not sensitive enough to detect the kinds of improvements that matter most to patients. This pilot study will explore whether novel, technology-based tests, delivered via tablets and virtual reality headsets, can better measure meaningful changes in vision and quality of life. These tools are designed to be more engaging and reflective of real-world visual tasks, such as navigating environments or detecting objects in low light. Fifty participants with neurodegenerative diseases affecting the optic nerve or retina will take part in the study. Researchers will assess how feasible and acceptable these new tools are to patients and whether the results they produce align more closely with patients' lived experiences. Ultimately, this research aims to improve how we assess vision in clinical trials, so that future treatments can be properly tested and approved based on measures that truly reflect patients' needs. If successful, it could lead to better-designed trials, more effective treatments, and improved quality of life for people living with visual impairment.

Conditions

Neurodegenerative Diseases; Inherited Optic Neuropathy

Outcome Measures

Primary Outcomes (2)

• Agreement of test performance with PROM

  Agreement between the tablet-based and virtual reality headset-based tests of real-world vision, with the patient's experience of their vision-related quality of life as assessed using a validated patient-reported outcome measure tool

  1 day

• Agreement of traditional measures of vision with PROM

  • Secondary comparison will be made between the patient's performance on traditional measures of vision and their response on the vision-related quality of life questionnaire.

  1 day

Secondary Outcomes (1)

• Experience of performing tests

  1 day

Interventions

Tablet- and virtual reality headset-based test of vision-related quality of life OTHER

* Tablet-based testing of functional vision * Virtual reality headset-based testing of functional vision * Questionnaire on experience of tests * Questionnaire on experience of vision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty participants with neurodegenerative diseases affecting the optic nerve or retina will take part in the study.

You may qualify if:

• Adults with neurodegenerative diseases affecting the optic nerve or retina who have sufficient manual dexterity to perform tablet-based and virtual reality headset-based tests. Informed consent will be received.

You may not qualify if:

• Those under the age of 18 years old
• Those who do not have sufficient manual dexterity to perform the tablet-based and virtual reality headset-based tests

Sponsors & Collaborators

• Nisha Nixon: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Neurodegenerative Diseases

Interventions

Tablets

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Nisha Nixon

CONTACT

01223 805000; nisha.nixon1@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Training Fellow

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03