Novel Technologies to Measure Vision-related Quality of Life

Официальное название

Feasibility Study of Novel Technologies to Measure Vision-related Quality of Life in Patients With Neurodegenerative Diseases Affecting the Optic Nerve or Retina

Обзор

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.

Вмешательства

• Другое Tablet- and virtual reality headset-based test of vision-related quality of life
  * Tablet-based testing of functional vision * Virtual reality headset-based testing of functional vision * Questionnaire on experience of tests * Questionnaire on experience of vision

Первичные конечные точки

• Agreement of test performance with PROM [Срок оценки: 1 day]
• Agreement of traditional measures of vision with PROM [Срок оценки: 1 day]

Вторичные конечные точки (1)

• Experience of performing tests [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07489898 · A097651

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗