Validation of the SightSave vision test
| ISRCTN | ISRCTN15358662 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15358662 |
| IRAS number | 324467 |
- Submission date
- 31/12/2022
- Registration date
- 07/02/2023
- Last edited
- 30/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and aims
We are aiming to compare the SightSave contrast sensitivity app that is performed on a touchscreen device with standard chart-based contrast sensitivity analysis. This will help determine if the SightSave contrast sensitivity app can be used at home by eye patients to check their eyesight.
Who can participate?
Individuals with cataracts who are due for standard cataract surgery with intraocular lens implant procedures.
What does the study involve?
Participants will have their vision tested using a range of 4m LogMAR contrast sensitivity charts and these results compared to the SightSave contrast sensitivity analyser at the same levels of contrast to validate the SightSave contrast sensitivity analyser pre and post cataract surgery to see if there is a comparable contrast sensitivity before and after surgery and if any improvements are recorded by the tests.
What are the possible benefits and risks of participating?
The benefits of participating in the study are that your vision will be very accurately measured before and after your surgery, the risks are that you are made aware of your poor vision, which might be upsetting.
Where is the study run from?
Edgbaston Eye Consultants (UK)
When is the study starting and how long is it expected to run for?
December 2022 to December 2023
Who is funding the study?
ScottHealth Ltd (UK)
Who is the main contact?
Prof. Robert AH Scott, rob.scott@scotthealth.co.uk
Contact information
Principal Investigator
Edgbaston Eye Consultants
22 George Road
Birmingham
B15 1PJ
United Kingdom
 ORCID ID |
0000-0003-3437-5698 |
|---|---|
| Phone | +44 1213144490 |
| rob.scott@scotthealth.co.uk |
Study information
| Study design | Method-comparison study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Comparative study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Validation of the SightSave contrast sensitivity application against standard logMAR constrast sensitivity charts |
| Study acronym | VASCA |
| Study objectives | The SightSave contrast sensitivity app generates similar measurements to standard contrast sensitivity chart testing |
| Ethics approval(s) | Approval pending, West Midlands – South Birmingham REC (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 207 104 8143; southbirmingham.rec@hra.nhs.uk) |
| Health condition(s) or problem(s) studied | Testing of contrast sensitivity |
| Intervention | Subjects will have their visual acuity measured using 4m logMAR visual acuity charts at contrast levels 1.25%, 2.5%, 5% ,10%, 25% and 100% and then use the SightSave contrast sensitivity app on a touchscreen device - all under standard conditions |
| Intervention type | Other |
| Primary outcome measure | LogMAR visual acuity at contrast levels 1.25%, 2.5%, 5%,10%, 25% and 100% measured using 4m logMAR visual acuity charts and the SightSave contrast sensitivity app on a touchscreen device |
| Secondary outcome measures | At the end of the testing: 1. Time taken to complete each test 2. 5 point scale evaluation by the patient of the ease of testing for them |
| Overall study start date | 10/12/2022 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 (50 eyes) |
| Key inclusion criteria | 1. Has visually significant cataract and listed for a cataract surgery with intraocular lens implant procedure 2. Patient consents to having contrast sensitivity testing on SightSave contrast sensitivity app and logMAR contrast sensitivity charts 3. Patient is able to use the logMAR charts and has capacity to read the letters |
| Key exclusion criteria | 1. Unable to use either or both, logMAR contrast sensitivity chart 2. Unable to read the chart letters |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 31/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Birmingham
B15 2NE
United Kingdom
Sponsor information
Research organisation
2 Pakenham Road
Birmingham
B15 2NE
England
United Kingdom
| Phone | +44 1212422160 |
|---|---|
| rich@agencyofdesign.co.uk | |
| Website | https://www.scotthealth.co.uk/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | For publication in peer-reviewed press |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from Robert AH Scott rob.scott@scotthealth.co.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 27/01/2023 | No | No |
Additional files
Editorial Notes
30/10/2023: Lower age limit (number and units) added.
08/02/2023: Internal review.
27/01/2023: Trial's existence confirmed by Sight Save.
