Study to validate a new test to measure contrast vision
| ISRCTN | ISRCTN87623837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87623837 |
| IRAS number | 291587 |
| Secondary identifying numbers | ID20-65, IRAS 291587 |
- Submission date
- 25/01/2021
- Registration date
- 29/01/2021
- Last edited
- 29/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
A very important aspect of vision is to be able to detect differences in shades (contrast). This is tested by a range of tests called contrast sensitivity and these tests are used to measure vision in particular in older people because this function decreases with age. A new test has become available and needs to be validated. The key validation is to measure if the test is repeatable (e. g. if we carry out the test twice on the same person do we get the same result). The aim of this study is to compare the repeatability of the new test with that of two current commercial tests.
Who can participate?
People aged 40 to 50 with normal vision other than needing glasses or contact lenses to see clearly at a distance.
What does the study involve?
The participants will come to the clinic three times. At the first visit, the participant's suitability to take part will be assessed and their vision correction will be determined. If suitable to take part the participants will come to the clinic twice within 1 week each time; during the two visits their vision will be tested with three different contrast sensitivity tests (the new test and two commercial tests).
What are to possible benefits and risks of participating?
There may be no direct benefits, but the data collected will help to develop a new test to better measure the vision of older people. There are no anticipated risks associated with taking part the tests are vision tests similar to those at the optician but more in-depth and taking longer so visual fatigue could occur.
Where is the study run from?
Ocular Technology Group - International (UK)
When is the study starting and how long it is expected to last?
October 2020 to November 2021
Who is funding the study?
Alcon LLC (USA)
Who is the main contact?
Deborah Moore
dmoore@otg.co.uk
Contact information
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)2072224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Single-centre repeated-measures participant-masked randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Letter contrast sensitivity testing in a young presbyopic phakic population |
| Study objectives | The hypothesis that will be tested in this test validation study is that the reliability of letter contrast sensitivity method is non-inferior to the repeatability of two commercially available sine grating contrast sensitivity test methods. |
| Ethics approval(s) | Approved 18/01/2021, East of England - Cambridge South Research Ethics Committee (The Gonville Hotel, Gonville Place, Cambridge, CB1 1LY, UK; +44 (0)2071048104; cambridgesouth.rec@hra.nhs.uk), REC ref: 20/EE/0276 |
| Health condition(s) or problem(s) studied | Evaluation of contrast sensitivity testing methods in a presbyopic phakic population |
| Intervention | Following a visit in which potential participants are screened, enrolled and familiarised with the testing procedures, participants will visit the clinic on two separate days within a 7-day period and will complete tests to evaluate their contrast sensitivity. Presentation of the test and two control tests will be randomised. Contrast sensitivity is measured at photopic (85 cd/m²) and mesopic (2.5 cd/m²) light levels using three different tests, one using letters of different contrasts and two using sinusoidal patterns of different contrasts: 1. OTG-i Vision Suite letter contrast sensitivity test 2. M&S Technologies linear sine wave grating test from the Clinical Trial Suite 3. Vector Vision standardized contrast sensitivity |
| Intervention type | Other |
| Primary outcome measure | Contrast sensitivity measured at photopic (85 cd/m²) and mesopic (2.5 cd/m²) light levels at up to five spatial frequencies: 18, 12, 6, 3 and 1.5 c/degree using: 1. OTG-i Vision Suite letter contrast sensitivity test 2. M&S Technologies linear sine wave grating test from the Clinical Trial Suite 3. Vector Vision standardized contrast sensitivity Measured twice up to 1 week apart |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 02/10/2020 |
| Completion date | 01/11/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Aged 40-50 years 2. Spectacle refraction: Distance: Sphere: -6.00D to +4.00D, Astigmatism: 0.00D to -3.00D, Near Addition: +0.50D to +2.50D 3. Best corrected visual acuity of at least 20/20 in each eye 4. Spectacles or soft contact lenses habitual visual correction 5. Have normal eyes with the exception of a need for visual correction 6. Have read and understood the Participant Information Sheet in English 7. Have read, signed and dated the Informed Consent 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| Key exclusion criteria | 1. Ocular anterior segment infection, inflammation, abnormality or active disease that would contraindicate contact lens wear 2. Newly prescribed (within past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilisers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eye drops which is not rewetting eyedrops for which contact lens wear would be contraindicated as determined by the investigator 3. Monocular patients (only one eye with functional vision) or participants fit with only one lens 4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy during the study period 7. Enrollment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals |
| Date of first enrolment | 01/02/2021 |
| Date of final enrolment | 31/07/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Research organisation
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)2072224224 |
|---|---|
| dmoore@otg.co.uk |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | There are no plans for public dissemination of results. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/01/2021: Trial's existence confirmed by East of England - Cambridge South Research Ethics Committee.
