Investigating methods of measuring visual field sensitivity in glaucoma
| ISRCTN | ISRCTN88711666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88711666 |
| IRAS number | 298826 |
| Secondary identifying numbers | IRAS 298826, CPMS 52475 |
- Submission date
- 20/04/2023
- Registration date
- 21/04/2023
- Last edited
- 05/06/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Glaucoma is characterised by a slow, irreversible loss of visual field. It is the world's leading cause of irreversible blindness, affecting about 500,000 people in England and Wales and 80 million people worldwide. With an ageing population, the prevalence of glaucoma is rising. Perimetry, the clinical method for identifying visual field loss, involves presenting stimuli (spots of light) on a screen and determining the dimmest that can be detected at multiple locations in the field. However, the current standard perimetry test was designed over 40 years ago, before the disease mechanisms in glaucoma were understood. There is a timely need to better understand how people with glaucoma detect perimetric stimuli, with 40 years of knowledge and understanding from basic science and clinical studies. The aim of this study is to better understand how patients with glaucoma respond to visual stimuli of different configurations. Specifically, the researchers will measure differences in the limits of vision and differences in variability between them.
Who can participate?
Patients over 40 years old with primary glaucoma or with no eye conditions. People who wear glasses or contact lenses for short-sightedness, long-sightedness or for reading will be eligible depending on their prescription.
What does the study involve?
Participants are invited to attend one of the research sites on one or more visits to undertake some measurements of their peripheral vision (visual field). Participants can choose to come to a research site in either Wales (Cardiff), Northern Ireland (Belfast or Coleraine), or England (London). Participants will undertake some standard clinical tests initially to confirm eligibility to participate. They will then undertake a series of visual field tests which will involve looking at a target at the centre of a screen and pressing a button when they see any spots appear in their peripheral vision. Only one eye (the eye that best meets the inclusion criteria) will be tested. Breaks will be given at regular intervals during testing and where requested.
What are the possible benefits and risks of participating?
There are no direct benefits for participants, except the knowledge that they are helping with research into ways of measuring the visual field in glaucoma. The visual tests are non-invasive and carry no more risk than watching television. There are no known side effects associated with them. All of the eligibility screening tests are performed with commercially available clinical equipment and are routinely carried out in an optometrist’s practice or hospital eye clinic and do not pose any risk to eye health. The eye pressure measurement will involve having a mild anaesthetic eye drop (as is standard in an optometrist’s practice or hospital eye clinic), but this will wear off after about 20 minutes. Participants are advised not to rub their eye during this time. Sometimes, during the course of research, an abnormality of the eye may be discovered which the participant had previously been unaware of. In the event of any previously undiscovered abnormality being detected during the course of this study, participants will be referred to the appropriate healthcare professional, with their consent, in the same manner as they would be referred by a local optometrist.
Where is the study run from?
This study is being run by Cardiff University, along with Ulster University and UCL (UK)
When is the study starting and how long is it expected to run for?
December 2021 to October 2025
Who is funding the study?
The Medical Research Council (MRC) (UK)
Who is the main contact?
1. Dr Tony Redmond, RedmondT1@cardiff.ac.uk
2. Becky Vangasse, VangasseR@cardiff.ac.uk
Contact information
Scientific, Principal Investigator
School of Optometry and Vision Sciences
Cardiff University
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
 ORCID ID |
0000-0002-6997-5231 |
|---|---|
| Phone | +44 (0)2920870564 |
| RedmondT1@cardiff.ac.uk |
Public
School of Optometry and Vision Sciences
Cardiff University
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
| Phone | + 44 (0)2920870564 |
|---|---|
| vangasser@cardiff.ac.uk |
Study information
| Study design | Multicentre cross-sectional observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | Novel perimetry for identifying changes in visual field sensitivity in glaucoma |
| Study acronym | REVAMP |
| Study hypothesis | Observational study: There is a timely need to better understand how people with glaucoma detect visual field test (perimetric) stimuli with 40 years of knowledge and understanding from basic science (physiological, psychophysical) and clinical studies. In this multi-disciplinary, multi-site project, we wish to better understand how people with glaucoma and normally-sighted individuals respond to visual stimuli and also gain an idea of how variable measurements are with each. |
| Ethics approval(s) | Approved 13/04/2022, London – Surrey Research Ethics Committee (Nottingham Centre, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)2071048388, surrey.rec@hra.nhs.uk), ref: 22/PR/0241 |
| Condition | Investigating peripheral visual sensitivity in people with glaucoma and normally-sighted individuals |
| Intervention | 1. Eligibility screening tests: 1.1. Questions about eye and general health history, family history, and current medications 1.2. Measurement of vision on a standard eye chart 1.3. Measurement of eye pressure, d) two visual field tests 1.4. Observation of the eye and screening for conditions that may affect vision 1.5. Measurement of eye length (non-invasive) 1.6. Retinal thickness scan with optical coherence tomography (OCT) 2. Measurement of visual sensitivity with psychophysics at multiple locations in the visual field. Investigations will be: 2.1. Differences in sensitivity between people with glaucoma and normally-sighted individuals 2.2. Variance in the sensitivity measures |
| Intervention type | Not Specified |
| Primary outcome measure | The difference in visual sensitivity between patients and normally-sighted individuals is measured at months 11, 22, and 39 |
| Secondary outcome measures | Variance of visual sensitivity in patients and normally-sighted individuals is measured at months 11, 22, and 39 |
| Overall study start date | 01/12/2021 |
| Overall study end date | 31/10/2025 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 157 patients with glaucoma; 230 normally-sighted individuals |
| Participant inclusion criteria | Patients with glaucoma: 1. Diagnosis of Primary Open Angle Glaucoma (POAG) or Normal Tension Glaucoma (NTG) by the hospital eye service 2. Visual field defect consistent with glaucomatous optic nerve appearance. 3. Stable IOP <21 mmHg 4. Refractive error < ±6.00DS and <3.50DC 5. Visual acuity of 6/9 (+0.3 logMAR) or better in the test eye, in the absence of significant corneal or media opacities 6. Age over 40 years Normally-sighted individuals: 1. No clinical diagnosis of glaucoma or other retinal disease 2. Full visual field 3. Healthy optic disc 4. No family history of glaucoma (first-degree) 5. Refractive error <±6.00DS and <3.50DC 6. Visual acuity of 6/9 (+0.3 logMAR) or better in the test eye, in the absence of significant corneal or media opacities 7. Age over 40 years |
| Participant exclusion criteria | 1. Any systemic disease and/or medication which is likely to affect visual performance (e.g. diabetes, thyroid disease) 2. Any ocular disease and/or medication that may affect visual performance (apart from glaucoma) 3. Any previous ocular surgery which may degrade visual performance (e.g. corneal graft, photodynamic therapy) 4. Inability to steadily fixate during the test (e.g. individuals who have nystagmus or macular degeneration) |
| Recruitment start date | 01/08/2022 |
| Recruitment end date | 15/10/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- United Kingdom
- Wales
Study participating centres
Maindy Road
Cathays
Cardiff
CF24 4HQ
United Kingdom
Coleraine
BT52 1SA
United Kingdom
Heath Park Way
Cardiff
CF14 4XW
United Kingdom
274 Grosvenor Rd
Belfast
BT12 6BA
United Kingdom
162 City Road
London
EC1V 2PD
United Kingdom
Sponsor information
University/education
Research Integrity, Governance and Ethics Team
Research and Innovation Services
Cardiff Joint Research Office
2nd Floor, Lakeside Building
University Hospital of Wales
Cardiff
CF14 4XW
Wales
United Kingdom
| Phone | + 44 (0)2920879277 |
|---|---|
| resgov@cardiff.ac.uk | |
| Website | https://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journal articles. |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from the Principal Investigator (Dr Tony Redmond; RedmondT1@cardiff.ac.uk), or via the Cardiff University Research Portal, after protection of IP and publication of the study findings. Requests for access will be reviewed by a panel comprising: the PI, one co-applicant from each of the study sites, and independent input from the chair of the Steering Committee |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/06/2024: The public contact was changed.
02/05/2023: Internal review.
21/04/2023: Trial's existence confirmed by the London – Surrey Research Ethics Committee.
