- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489898
Novel Technologies to Measure Vision-related Quality of Life (Tablet-VR)
Feasibility Study of Novel Technologies to Measure Vision-related Quality of Life in Patients With Neurodegenerative Diseases Affecting the Optic Nerve or Retina
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nisha Nixon
- Phone Number: 01223 805000
- Email: nisha.nixon1@nhs.net
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement of test performance with PROM
Time Frame: 1 day
|
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
Time Frame: 1 day
|
• 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experience of performing tests
Time Frame: 1 day
|
• The secondary endpoint will be the subjective experience of the tablet-based and virtual reality headset-based tests, as measured by questionnaire surveys.
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A097651
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurodegenerative Diseases
-
Fujian Medical University Union HospitalRecruitingNeurodegenerative DisordersChina
-
University of OviedoUniversity of LeonCompleted
-
Imperial College LondonWithdrawn
-
University Hospital, Strasbourg, FranceRecruitingNeurodegenerative DisordersFrance
-
First Affiliated Hospital of Fujian Medical UniversityRecruitingNeurodegenerative DisordersChina
-
University of PennsylvaniaAvid RadiopharmaceuticalsRecruiting
-
The University of Hong Konghealth bureau, hong kongActive, not recruiting
-
ACADIA Pharmaceuticals Inc.CompletedNeuropsychiatric Symptoms Related to Neurodegenerative DiseaseUnited States, Russian Federation, Serbia, Poland, Georgia, Czechia, Bulgaria, Colombia, Mexico, Romania, South Africa, Ukraine
-
ACADIA Pharmaceuticals Inc.CompletedNeuropsychiatric Symptoms Related to Neurodegenerative DiseaseSerbia, United States, Poland, Georgia, Russian Federation, Bulgaria, Colombia, Czechia, Mexico, Romania, South Africa, Ukraine
-
University of Illinois at Urbana-ChampaignRecruitingAdults | Mindfulness | EEG | Neurodegenerative DiseaseUnited States
Clinical Trials on Tablet- and virtual reality headset-based test of vision-related quality of life
-
Wills EyeMerck Sharp & Dohme LLCCompleted
-
Assistance Publique - Hôpitaux de ParisVR 4 GOODRecruitingPain, Postoperative | Colon Tumor, Malignant | Rectum TumorFrance
-
University of Maryland, BaltimoreNational Center for Advancing Translational Sciences (NCATS); University of...CompletedTrauma | Traumatic Brain Injury | Pain, Acute | Headaches PosttraumaticUnited States
-
University of PittsburghRecruitingProstate CancerUnited States
-
Imperial College LondonBarking, Havering and Redbridge University Hospitals NHS Trust; Imperial College... and other collaboratorsActive, not recruitingQuality of Life | Oesophageal Cancer | Bacterial OvergrowthUnited Kingdom
-
University of SevilleNot yet recruiting
-
Ciusss de L'Est de l'Île de MontréalPaperplane TherapeuticsNot yet recruitingVirtual Reality | PropofolCanada
-
Ain Shams UniversityCompletedT1DM | Insulin Pump | Health Related Quality of LifeEgypt
-
Shanghai Jiao Tong University School of MedicineGuizhou Provincial People's Hospital; The Third Xiangya Hospital of Central... and other collaboratorsRecruitingB-Cell Lymphoblastic LeukemiaChina