Visual and Functional Assessment in Low Vision Patients
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|ClinicalTrials.gov Identifier: NCT01876147|
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : June 13, 2019
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|Condition or disease|
|Retinitis Pigmentosa Age-related Macular Degeneration Optic Nerve Pathology Inherited Retinal Dystrophies|
Assessing very low vision accurately is becoming increasingly important with the increase in research in this area, such as using retinal implants to restore vision. Without being able to accurately measure the change in vision before and after treatment, it is not possible to fully assess the effect of treatment.
The Freiburg Vision Test (FrACT) is a computer based test developed to assess patients down to the LP level. It has been used in research in recent years. The FrACT is suitable for research but is not suitable for a clinical setting. The Berkeley Rudimentary Vision Test (BRVT) works on a similar principal as the FrACT but consists of hand held cards shown to the patient. Little work has been completed on how well the BRVT test works. Results from FrACT and BRVT will be compared in a group of patients with very low vision. This is important to establish how easily research results can be applied to a clinical setting.
Patients will also be asked to complete a daily living survey to better understand the impact of such poor vision on the ability to carry out day to day tasks. This understanding will help guide low vision services for patients as well as help direct low vision research to achieve a useful level of functional vision.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||A Randomised Crossover Study to Assess the Usability of Two New Vision Tests in Patients With Low Vision, and Relationship of the Measures to Daily Living Tasks.|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Order of vision tests 1
Undergo testing with BRVT first, FrACT second.
Order of vision tests 2
Undergo testing with FrACT first, BRVT second.
- Comparison of VA measured with FrACT and BRVT vision tests [ Time Frame: Single visit ]
- Relationship between VA and ability to carry out daily living tasks. [ Time Frame: Single time point ]Results from a daily living skills survey will be related to VA measured by FrACT testing.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Snellen VA or equivalent ≤ 6/60 in both eyes
- Patient has capacity to give consent and to undertake vision tests
- Diagnosis of functional vision loss
- Unwilling and/or unable to sign informed consent and complete the vision tests
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876147
|Oxford University Hospitals NHS Trust|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Principal Investigator:||Robert E MacLaren, DPhil||University of Oxford|
Publications of Results:
|Responsible Party:||University of Oxford|
|Other Study ID Numbers:||
|First Posted:||June 12, 2013 Key Record Dates|
|Last Update Posted:||June 13, 2019|
|Last Verified:||October 2018|
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Nervous System Diseases