Assessment of the EyeVdoc App
| ISRCTN | ISRCTN58473467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58473467 |
- Submission date
- 23/08/2023
- Registration date
- 31/08/2023
- Last edited
- 29/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Common eye conditions account for a significant number of clinical visits, with health care clinicians – these maybe GP, optometrist, pharmacists, nurse, AHP or A&E departments. In some areas of the UK there are NHS funded services, for patients to present to a community optometrist (these are called Minor Eye Care services, or Optometry first) the outcome of these visits, for common external eye conditions, is often reassurance or advice on self-management. Where optometry services are not available, it can result in patients attending multiple visits with various clinicians. Considering the capacity and financial pressures on the NHS, this tool could help support capacity issues and reduce financial costs for the NHS.
Who can participate?
Adults over 18 years, with a range of eye conditions.
What does the study involve?
Participants are selected after they have been seen by an eye care health professional. The study involves visiting the website https://www.eyevdoc.com. Participants will be asked to complete the online consenting process, then enter some information about age, gender, ethnicity and then take and upload images of the eye using a smartphone camera.
What are the possible benefits and risks of participating?
None
Where is the study run from?
EyeV Ltd (UK)
When is the study starting and how long is it expected to run for?
August 2023 to October 2024
Who is funding the study?
EyeV Ltd (UK)
Who is the main contact?
Adam Holliday, adam@eyev.health
Contact information
Principal Investigator
East West Building
2 Tollhouse Building
Nottingham
NG1 5FS
United Kingdom
 ORCID ID |
0000-0002-5655-7305 |
|---|---|
| Phone | +44 7446019842 |
| adam@eyev.health |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Optician |
| Study type | Diagnostic |
| Participant information sheet | https://www.eyevdoc.com/participant-information/ |
| Scientific title | To assess the precision of a machine learning tool, to diagnose a range of common external eye conditions |
| Study objectives | To determine the precision of a machine learning tool, to diagnose a range of common external eye conditions using smartphone camera. |
| Ethics approval(s) |
Not yet submitted, HRA (United Kingdom) |
| Health condition(s) or problem(s) studied | Ptosis, Dermatochalasis, Blepharochalasis, Allergic conjunctivitis, Bacterial conjunctivitis, Dry eye, Anterior uveitis, External hordeolum, Internal hordeolum, Entropion, Ectropion, Blepharitis, Pterygium, Pingquela, Anisocoria, Sub conjunctival haemorrhage, Episcleritis |
| Intervention | There are two arms to this study, for data collection. Retrospective analysis of external eye images From an existing clinical service (Leicestershire, COVID urgent eye service) using images which were provided by patients as part of their clinical care and which a diagnosis was made by a clinician. Consent to use images was given by patients, for use in their clinical care but not for research. A new consent process would be undertaken for use of the images for research process. Prospective data collection Patient presents to a community optometrists/ophthalmologist, who performs a clinical assessment, provides diagnosis, treatment and management. If the patient has one of the eye conditions being considered, the clinician will discuss the study with the patient and if interested in participating, provides the participant with the PIS EyeVdoc leaflet. The clinician will indicate on the PIS EyeVdoc leaflet the clinical diagnosis(s). The participant can then enrol into the online study at a convenient time after the clinical visit. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | EyeVdoc App |
| Primary outcome measure | Precision of the EyeVdoc app measured using the EyeVdoc app diagnosis compared to a clinical diagnosis at a single time point. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 23/08/2023 |
| Completion date | 01/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | Both |
| Target number of participants | 170 |
| Key inclusion criteria | 1. Age: 18 yrs and over 2. Ability to consent 3. Being diagnosed with one of the below external eye conditions 3.1. Ptosis 3.2. Dermatochalasis 3.3. Blepharochalasis 3.4. Allergic conjunctivitis 3.5. Bacterial conjunctivitis 3.6. Dry eye 3.7. Anterior uveitis 3.8. External hordeolum 3.9. Internal hordeolum 3.10. Entropion 3.11. Ectropion 3.12. Blepharitis 3.13. Pterygium 3.14. Pingquela 3.15. Anisocoria 3.16. Sub conjunctival haemorrhage 3.17. Episcleritis |
| Key exclusion criteria | No smartphone |
| Date of first enrolment | 01/10/2023 |
| Date of final enrolment | 01/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Huddersfield Road
Halifax
HX3 0PW
United Kingdom
Sponsor information
Industry
East West Building
2 Tollhouse Hill
Nottingham
NG1 5FS
England
United Kingdom
| Phone | +44 7540258918 |
|---|---|
| cellan@eyev.health | |
| Website | https://www.eye.health |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Adam Holliday adam@eyev.health |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 21/07/2023 | 29/08/2023 | No | No |
Additional files
Editorial Notes
29/08/2023: Trial's existence confirmed by Calderdale & Huddersfield NHS Foundation Trust.
