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| Name | Class |
|---|---|
| University of Sussex | OTHER |
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Purpose:
To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.
Aims of the Research Project:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Headset based tests | Device | Visual task tests based on Oculus Rift |
| Measure | Description | Time Frame |
|---|---|---|
| Test repeatability | Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2. | All statistical analysis will take place once all data collection has ended, average 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use and acceptability questionnaire | Modified from Tay et al, Br J Ophthalmol 2004;88:719-720 Ask the following questions for virtual reality test:
|
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Inclusion Criteria:
Male and female participants
Age 20-50
Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
Sight impairment criteria are as follows:
Exclusion Criteria:
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Patients with Stargardt's disease, advanced retinitis pigmentosa and Albinism.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth Hogg, PhD | Contact | 02890971654 | r.e.hogg@qub.ac.uk | |
| Lucie Dalton, BSc | Contact | l.dalton@qub.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ruth E Hogg, PhD | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NI Clinical Research Facility | Recruiting | Belfast | Northern Ireland | BT9 7AB | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2016 |
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| Responses from all participants will be collated and summarised at the end of the study, average 1 year. |
| Mar 4, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015354 | Vision, Low |
| D012174 | Retinitis Pigmentosa |
| D000080362 | Stargardt Disease |
| C535805 | Stargardt disease 3 |
| C535521 | Stargardt disease 4 |
| D000417 | Albinism |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015785 | Eye Diseases, Hereditary |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008268 | Macular Degeneration |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D012873 | Skin Diseases, Genetic |
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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