Contrast sensitivity evaluation using different glare levels
| ISRCTN | ISRCTN17860990 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17860990 |
| Integrated Research Application System (IRAS) | 362627 |
| Sponsor | Ocular Technology Group Ltd |
| Funder | Alcon Research LLC |
- Submission date
- 26/11/2025
- Registration date
- 26/11/2025
- Last edited
- 26/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims:
As per the ISO the glare produced by intraocular lenses can be evaluated using the glare level that produces a contrast loss of 0.1 log contrast at 6 cycles per degree spatial frequency. This study aims to determine the glare level required by the ISO using three different contrast sensitivity systems as follows:
1. M & S Technologies linear sine wave gratings contrast sensitivity test at mesopic light level (2.5 to 3 cd/2) under four glare conditions: no glare, glare level 1, glare level 2, glare level 3
2. M & S Technologies sinusoidal bulls eye contrast sensitivity test at mesopic light level (2.5 to 3 cd/2) under four glare conditions: no glare, glare level 1, glare level 2, glare level 3
3. OTG-i Vision Suite timed letter contrast sensitivity test at mesopic light level (2.5 to 3 cd/2) under four glare conditions: no glare, glare level 1, glare level 2, glare level 3
Who can participate?
Participants aged between 45 and 55 years old
What does the study involve?
The study involves attending the clinic for two study visits:
Visit 1: Screening/enrollment/study test familiarization
Visit2: Study tests/discharge. The following tests will be carried out in random order and for each test no glare will be tested first, and the order of testing of the three glare levels will be randomized:
1. M & S Technologies sinusoidal linear contrast sensitivity test
2. M & S Technologies sinusoidal bulls eye contrast sensitivity test
3. OTG-i timed letter contrast sensitivity test
What are the possible benefits and risks of participating?
The study will collect information to test the disability glare produced by intraocular lenses.
Where is the study run from?
Ocular Technology Group - International (OTG-i) (UK)
When is the study starting and how long is it expected to run for?
November 2025 to June 2026
Who is funding the study?
Alcon Research, LLC (USA)
Who is the main contact?
Deborah Moore, dmoore@otg.co.uk
Contact information
Principal investigator, Scientific
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)2072224224 |
|---|---|
| mguillon@otg.co.uk |
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)2072224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Randomized (order of testing) cross-over study design |
| Scientific title | Method optimization for evaluating contrast sensitivity using different glare levels |
| Study objectives | The objective of the pilot study will be to determine the light outputs producing a contrast sensitivity loss of 0.1 log contrast or closest for the M & S Technologies linear sine wave gratings contrast sensitivity, M & S sinusoidal bulls eye contrast sensitivity and OTG-i letter contrast sensitivity tests at 2.5 to 3 cd/m2 for both the overall study population. |
| Ethics approval(s) |
Approved 14/11/2025, London - Riverside Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8150; riverside.rec@hra.nhs.uk), ref: 25/LO/0724 |
| Health condition(s) or problem(s) studied | Glare produced by intraocular lenses |
| Intervention | Up to 50 potential participants will attend the research clinic for their first visit to initially obtain their informed consent and to screen them for their suitability to take part in the investigation Then the participants will be familiarized with the study tests. At Visit 2 the following tests will be carried out in random order and for each test no glare will be tested first, and the order of testing of the three glare levels will be randomized: 1. M & S Technologies sinusoidal linear contrast sensitivity test 2. M & S Technologies sinusoidal bulls eye contrast sensitivity test 3. OTG-i timed letter contrast sensitivity test |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Age 45 to 55 years 2. Spectacle refraction: Distance: Sphere: -4.00D to + 2.00D Astigmatism: 0.00D to -0.75 3. Best corrected distance visual acuity of at least 20/20 in each eye 4. Clear media 5. No ocular comorbidity |
| Key exclusion criteria | 1. Any history of eye disease, injury or abnormality that affects any part of the eye that affects vision 2. Any active eye disease that affects any part of the eye that affects vision 3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 4. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or ocular medication that may affect vision and its stability as determined by the investigator. 5. Enrolment of the 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 | 21/11/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SW1E 6AU
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
26/11/2025: Study's existence confirmed by the London - Riverside Research Ethics Committee.
