Monofocal IOL Visual Performance Quantification
Research type
Research Study
Full title
Technology Validation and Optimization for Monofocal Intra Ocular Lens Visual Performance Quantification
IRAS ID
253925
Contact name
Kishan Patel
Contact email
Sponsor organisation
OCULAR TECHNOLOGY GROUP - International
Duration of Study in the UK
0 years, 7 months, 7 days
Research summary
Monofocal Intra-Ocular Lenses (single vision lenses implanted inside the eye after cataract removal i.e. IOL) typically allows the user/patient to see well at far distance. In the clinic setting, to test how well IOL corrects the vision is by a single measurement of visual acuity (VA) with high contrast chart (black letters on white background) under good lighting condition. The problem is that when patients are asked about their satisfaction with their vision (patient reported outcome - PRO), the responses do not match the VA measurement. The reason is because VA is measured under a single very specific set up, while the IOL needs to give good vision under various and different contrasts (e. g. grey shades), lighting conditions (e.g. outdoor daytime and night time, indoor and in a limited time). Hence, this study will measure the vision with Monofocal IOL using a comprehensive set of vision tests to determine how well the IOL performs under a representative range of vision situations. The study population will be participants who had successful cataract surgery and were implanted with single vision IOL in both eyes. The study will be conducted at an independent research clinic, involving a single visit of approximately 5 hours and thirty participants. The environment for the VA measurement will be controlled (i.e. contrast, lighting, time). The study will be funded by a grant for Investigator Initiated Study and subjects will be recruited from Optegra clinic.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0539
Date of REC Opinion
8 Nov 2018
REC opinion
Further Information Favourable Opinion