Retinitis PigmentosaNCT01876147
Visual and Functional Assessment in Low Vision Patients
An observational study of Retinitis Pigmentosa and Age-related Macular Degeneration, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Vision testing is a fundamental part of every optometry and ophthalmology assessment. Traditional vision testing charts are not able to measure vision below a certain level. Vision in this range is classified as counting fingers (CF), hand movements (HM) and light perception (LP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa, Age-related Macular Degeneration, Optic Nerve Pathology
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with low vision attending outpatient clinics in Oxford Eye Hospital.
Who may be able to join
- Snellen VA or equivalent ≤ 6/60 in both eyes
- Patient has capacity to give consent and to undertake vision tests
Who cannot join
- Diagnosis of functional vision loss
- Unwilling and/or unable to sign informed consent and complete the vision tests
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 9DU
About this study
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.
Vision testing is a fundamental part of every optometry and ophthalmology assessment. Traditional vision testing charts are not able to measure vision below a certain level. Vision in this range is classified as counting fingers (CF), hand movements (HM) and light perception (LP). These measures are not very accurate or easily quantifiable. They are also poorly understood in terms of impact on quality of life. This study aims to assess new methods for measuring the vision of patients with very low vision.
Read the detailed description
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.
- Conditions
- Retinitis Pigmentosa, Age-related Macular Degeneration, Optic Nerve Pathology, Inherited Retinal Dystrophies
- Keywords
- Low vision, Vision testing, Retinitis Pigmentosa, AMD, Visual acuity, Poor vision, Quantification
- Medical subject headings
- Retinitis Pigmentosa, Macular Degeneration, Vision, Low, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Order of vision tests 1 | Undergo testing with BRVT first, FrACT second. | |
| Order of vision tests 2 | Undergo testing with FrACT first, BRVT second. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of VA measured with FrACT and BRVT vision tests
Measured: Single visit
Secondary outcomes (1)
Relationship between VA and ability to carry out daily living tasks.
Results from a daily living skills survey will be related to VA measured by FrACT testing.
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert E MacLaren, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876147
- Sponsor's protocol ID
- OxfordVA2013
- Status last verified
- Oct 2018
- First submitted
- 10 Jun 2013
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Jolly JK, Gray JM, Salvetti AP, Han RC, MacLaren RE. A Randomized Crossover Study to Assess the Usability of Two New Vision Tests in Patients with Low Vision. Optom Vis Sci. 2019 Jun;96(6):443-452. doi: 10.1097/OPX.0000000000001380.
PubMed 31058709
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01876147
- Acronym / sponsor ID
- OxfordVA2013
- Conditions
- Retinitis Pigmentosa, Age-related Macular Degeneration, Optic Nerve Pathology, Inherited Retinal Dystrophies
- Keywords
- Low vision, Vision testing, Retinitis Pigmentosa, AMD, Visual acuity, Poor vision, Quantification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vision testing is a fundamental part of every optometry and ophthalmology assessment. Traditional vision testing charts are not able to measure vision below a certain level. Vision in this range is classified as counting fingers (CF), hand movements (HM) and light perception (LP). These measures are not very accurate or easily quantifiable. They are also poorly understood in terms of impact on quality of life. This study aims to assess new methods for measuring the vision of patients with very low vision.
Detailed description
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Order of vision tests 1 | – | –Undergo testing with BRVT first, FrACT second. |
| Order of vision tests 2 | – | –Undergo testing with FrACT first, BRVT second. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low vision attending outpatient clinics in Oxford Eye Hospital.
Key inclusion criteria (2 listed)
- Snellen VA or equivalent ≤ 6/60 in both eyes
- Patient has capacity to give consent and to undertake vision tests
Key exclusion criteria (2 listed)
- Diagnosis of functional vision loss
- Unwilling and/or unable to sign informed consent and complete the vision tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of VA measured with FrACT and BRVT vision tests
Time frame: Single visit
1 secondary outcome
Relationship between VA and ability to carry out daily living tasks.
Time frame: Single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Results publication: PubMed 31058709Jolly JK, Gray JM, Salvetti AP, Han RC, MacLaren RE. A Randomized Crossover Study to Assess the Usability of Two New Vision Tests in Patients with Low Vision. Optom Vis Sci. 2019 Jun;96(6):443-452. doi: 10.1097/OPX.0000000000001380.
- Related InfoLink provided by the sponsor.
Related trials for Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
Active, not recruitingObservational study
Rate of Progression in USH2A-related Retinal Degeneration
Usher Syndrome, Type 2A, Retinitis Pigmentosa 39
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E MacLaren, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa and Age-related Macular Degeneration, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of VA measured with FrACT and BRVT vision tests (time frame: Single visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01876147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.