Study of technologies for the diagnosis of angle closure glaucoma
| ISRCTN | ISRCTN15115867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15115867 |
| IRAS number | 315388 |
| Secondary identifying numbers | B22/08, CPMS 55578, IRAS 315388 |
- Submission date
- 25/01/2023
- Registration date
- 10/03/2023
- Last edited
- 01/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
The ACE study is trying to find out whether people referred by an optician with possible angle closure could be safely diagnosed by healthcare professionals other than eye doctors. Patients will be helping us to determine whether other health professionals besides eye doctors could look after people who have been referred to the eye clinic with angle closure. If the research confirms that this is the case, this will relieve doctors’ time in the NHS and doctors could then see patients with serious eye diseases who require treatment more promptly. In the long term, this would potentially help with waiting times in the NHS. If the study shows that having other health professionals see patients once they are stable is not as good as having doctors evaluating them, then this strategy will not be implemented in the NHS.
Who can participate?
Adults (≥18 years) referred from community optometry to hospital eye services with suspected angle closure
What does the study involve?
Some images will be obtained from the front of the patient's eyes and the patient will also be seen by an optometrist and an eye doctor at the clinic. Some information about participants will be noted in relation to age, gender, postcode, prescription glasses etc and patients will also be asked to complete a quality-of-life questionnaire.
What are the possible benefits and risks of participating?
Patients will be helping us to determine whether other health professionals besides eye doctors could look after people referred to the eye clinic with angle closure. If this is the case this will relieve doctors' time in the NHS and doctors could then see patients who need treatment more promptly. Participants may help with waiting times in the NHS. There are no risks associated with the study.
Where is the study run from?
Queens University Belfast (UK)
When is the study starting and how long is it expected to run for?
July 2022 to August 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (UK)
Who is the main contact:
1. Ms Mary Guiney (Public), mary.guiney@nictu.hscni.net
2. Prof. Augusto Azura Blanco, (Scientific) a.azuara-blanco@qub.ac.uk
Contact information
Principal Investigator
Centre for Public Health
Institute of Clinical Science A
Queen's University Belfast
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
 ORCID ID |
0000-0002-4805-9322 |
|---|---|
| Phone | +44 (0)28 9097 6350 |
| a.azuara-blanco@qub.ac.uk |
Public
Northern Ireland Clinical Trials Unit (NICTU)
7 Lennoxvale
Belfast
BT9 5BY
United Kingdom
| Phone | +44 (0)28 9615 1447 |
|---|---|
| ACE@nictu.hscni.net |
Study information
| Study design | Prospective cross-sectional multi-centre diagnostic study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, Optician |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Study of technologies for the diagnosis of angle closure glaucoma (ACE) |
| Study acronym | ACE |
| Study hypothesis | That the two non-contact tests being investigated for diagnosing angle closure glaucoma will be accurate and facilitate a safe and efficient pathway for patients with this condition compared with gonioscopy (reference standard) by an expert consultant ophthalmologist |
| Ethics approval(s) | Approved 19/12/2022, London - City & East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0) 207 104 8171; cityandeast.rec@hra.nhs.uk), ref: 22/LO/0885 |
| Condition | Angle-closure glaucoma |
| Intervention | This is a diagnostic accuracy study. The tests will be used for triage. The study aims to propose a novel patient pathway. To evaluate the diagnostic performance of two non-contact diagnostic tests compared to gonioscopy (reference standard) by an expert consultant ophthalmologist. Anterior segment optical coherence tomography (AS-OCT) will be interpreted by optometrists and photographers/imaging technicians and ophthalmologists. Limbal anterior chamber depth (LACD), will be interpreted by optometrists. There is one visit per patient at the hospital eye clinic services. Testing will be carried out face to face, on an individual basis per patient. |
| Intervention type | Other |
| Primary outcome measure | Sensitivity and specificity of the new pathway to detect angle-closure glaucoma measured using standard formulas and pre-specified criteria for test positivity. All tests will be done at the same clinic visit. |
| Secondary outcome measures | The following outcome measures will be assessed and recorded in patient notes at the same clinic visit: 1. Positive/negative likelihood ratios for angle-closure glaucoma development measured using standard formulas 2. Concordance measured using standard formulas 3. Long-term health and cost outcomes measured using a Markov model run over an expected lifetime time horizon 4. Proportion of patients requiring subsequent clinical assessment by ophthalmologist measured using descriptive statistics 5. Proportion of patients unable to undergo tests and of tests of inadequate quality measured using descriptive statistics 6. Health-related quality of life measured using the EuroQol Health Questionnaire (EQ-5D-5L) |
| Overall study start date | 01/07/2022 |
| Overall study end date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 600 |
| Participant inclusion criteria | Adults (≥18 years) referred from community optometry to hospital eye services with suspected angle closure glaucoma |
| Participant exclusion criteria | Unable to provide informed consent |
| Recruitment start date | 03/04/2023 |
| Recruitment end date | 30/07/2024 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
162 City Road
London
EC1V 2PD
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Dudley Road
Birmingham
B18 7QH
United Kingdom
London
SE5 9RS
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
University/education
Queen's University Belfast
63 University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom
| Phone | +44 (0)28090245133 |
|---|---|
| researchgovernance@qub.ac.uk | |
| Website | http://www.qub.ac.uk/ |
"ROR" |
https://ror.org/00hswnk62 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is anticipated that the study findings will be published in national and international peer review journals and these articles will be led by the CI. This will secure a searchable compendium of these publications and make the results readily accessible to the public and healthcare professionals. In addition, study findings may be presented at both national and international meetings and to appropriate patient groups. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request following the publication of the primary and secondary outcomes. Formal requests for data should be made in writing to Prof. Augusto Azura-Blanco (Chief Investigator) via the Trial Manager, Mary Guiney (ACE@nictu.hscni.net). Requests will be reviewed on a case-by-case basis in collaboration with the Sponsor. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Protocol article | 04/10/2023 | 05/10/2023 | Yes | No |
Editorial Notes
01/08/2024: The recruitment end date was changed from 31/12/2024 to 30/07/2024. Total final enrolment added.
15/02/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/08/2024 to 31/12/2024.
2. The overall study end date was changed from 31/08/2024 to 31/12/2024.
14/12/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2023 to 31/08/2024.
2. The overall study end date was changed from 31/12/2023 to 31/08/2024.
3. The intention to publish date was changed from 31/12/2024 to 30/06/2025.
05/10/2023: Publication reference added.
26/01/2023: Trial's existence confirmed by NIHR (UK).
