Visual function in retinal degeneration
| ISRCTN | ISRCTN24016133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24016133 |
| IRAS number | 286579 |
| Secondary identifying numbers | IRAS 286579, CPMS 47247, NIHR202821 |
- Submission date
- 17/08/2022
- Registration date
- 18/08/2022
- Last edited
- 16/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The study uses some of the most up-to-date techniques to assess different aspects of vision in patients with retinal degeneration. Visual function tests allow measurement of the level of vision such as reading letters on a letter chart. Whereas visual field assessments involve measuring the size of a seen area or the eyes' sensitivity to a particular light level in an area. Ocular imaging involves using a number of devices to capture images of the retina, the light-sensitive part of the eye. This study will enable us to use the latest tests and assessment methods to determine the suitability and usefulness of these visual assessments in patients with inherited retinal disease.
Who can participate?
Health volunteers can participate as well as patients with a genetically confirmed inherited retinal disease.
What does the study involve?
The study involves completing a series of letter chart tests and central visual field tests. Tests are completed on each eye and then repeated on the right eye. For patient participants, the study involves the completion of questionnaires about their vision. Some patient participants will also be invited to take part in a recorded interview to understand how they found the different tests.
What are the possible benefits and risks of participating?
There is no direct participant benefit from taking part in the research aside from
contributing to knowledge to improve future patient care.
The extra tests may be slightly tiring, participants will be able to take breaks when needed.
There is a risk that an unknown eye condition in control participants could be detected, if this occurs the participant will be advised to go to their optometrist for an eye test.
Where is the study run from?
Oxford Eye Hospital, Oxford, England (UK)
When is the study starting and how long is it expected to run for?
May 2020 to January 2024
Who is funding the study?
This project is funded by the National Institute for Health and Care Research (NIHR) (UK) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR202821).
Who is the main contact?
Laura Taylor, trials@eye.ox.ac.uk
Contact information
Principal Investigator
Oxford Eye Hospital, LG 1 West Wing, John Radcliffe Hospital, Headington
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0001-7072-0853 |
|---|---|
| Phone | 01865 231122 |
| trials@eye.ox.ac.uk |
Study information
| Study design | Single-centre prospective cross-sectional observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 42246 Control PIS V3.0 21Jan2022.pdf |
| Scientific title | A cross-sectional study to assess the clinical utility of modern visual function assessments in patients with inherited retinal disease |
| Study acronym | VFIRD |
| Study objectives | To investigate the clinical utility of degeneration targeting tests of visual function and compare them to the standard measures currently used in patients with retinitis pigmentosa. |
| Ethics approval(s) | Approved 17/01/2022, West Midlands - Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 207 104 8141; blackcountry.rec@hra.nhs.uk), ref 20/WM/0283 |
| Health condition(s) or problem(s) studied | Visual function in patients with inherited retinal disease |
| Intervention | There will be two arms to the study. The first arm will include control participants. The second arm will include patient participants with confirmed inherited retinal disease. All participants will undergo the same visual field and visual acuity tests. Patient participants will also complete questionnaires. The assessments will take place during a single visit lasting no longer than 120 minutes with breaks included if required, this is in addition to the routine clinical care appointment which typically lasts around 120 minutes including waiting time. |
| Intervention type | Other |
| Primary outcome measure | VIsual function measured at a single time point: 1. Visual acuity 2. Low luminance visual acuity 3. Mesopic microperimetry |
| Secondary outcome measures | Visual function measures and visual field tests measured at a single time point: 1. Moorfields Acuity Chart Test 2. Scotopic Microperimetry 3. Low Luminance Questionnaire 4. Obtain qualitative data via semistructured interviews of patient participants in the day following completion of the study tests. The interviews will explore how the tests made the participants feel and whether any changes or improvements can be made to make the tests more acceptable and accessible. |
| Overall study start date | 01/05/2020 |
| Completion date | 01/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 40 patient participants and 40 healthy controls |
| Total final enrolment | 81 |
| Key inclusion criteria | Patient participants: 1. Participant is willing & able to give informed consent for participation in the study. 2. Male or female, aged 16 years or above, there is no upper age limit. 3. An inherited retinal degeneration diagnosis 4. A minimum of 6/60 standard VA in each eye. 5. Able to participate in visual function testing. Control participants: 1. Participant is willing & able to give informed consent for participation in the study. 2. Male or female, aged 16 years or above, there is no upper age limit. 3. A minimum standard VA of 6/7.5 in each eye – this will only become apparent once the participant starts the study, if it is clear they do not meet this criterion, they will be excluded from the study and no further testing undertaken. 4. Able to participate in visual function testing. |
| Key exclusion criteria | Patient participants: 1. Pre-existing amblyopia or squint would exclude that eye, but other eye still eligible 2. History of other eye problems except those relevant to the study, or glasses or contact lenses, if eye problem in just one eye, the other eye is still eligible 3. Been involved in an interventional research trial where they have received a treatment for their eye condition. Control participants: 1. Pre-existing amblyopia or squint, fellow eye still eligible 2. History of eye problems, eye treatment or eye surgery other than glasses or contact lenses, if in one eye, fellow eye still eligible. |
| Date of first enrolment | 13/08/2021 |
| Date of final enrolment | 01/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
West Wing
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
Research Governance, Ethics & Assurance (University of Oxford)
Joint Research Office
Boundary Brook House
Churchill Drive
Oxford
OX3 7GB
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publications in high-impact peer-reviewed journals |
| IPD sharing plan | A data management plan has been created. Results will be made available by the publicly available University of Oxford data repository upon completion of the study and publication of study results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Control version 3.0 |
21/01/2022 | 17/08/2022 | No | Yes |
| Participant information sheet | Patient version 4.0 |
11/04/2022 | 17/08/2022 | No | Yes |
| Protocol article | 24/05/2023 | 25/05/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/07/2025 | 16/06/2025 | Yes | No |
Additional files
- 42246 PIS V4.0 11Apr22.pdf
- Patient
- 42246 Control PIS V3.0 21Jan2022.pdf
- Control
Editorial Notes
16/06/2025: Publication reference added.
17/01/2024: Total final enrolment added.
25/05/2023: Publication reference added.
06/04/2023: The IPD sharing statement has been changed and the IPD sharing summary updated accordingly.
17/08/2022: Trial's existence confirmed by West Midlands - Black Country Research Ethics Committee.
